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Muscle Mass Changes After Daily Consumption of Protein Mix Supplemented With Vitamin D in Adults Over 50 Years of Age: Subgroup Analysis According to the Serum 25(OH)D Levels of a Randomized Controlled Trial.
Kang, Y, Kim, N, Lee, Y, An, X, Chung, YS, Park, YK
Clinical nutrition research. 2023;12(3):184-198
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Sarcopenia is an age-related decrease in muscle mass and strength and increases the risk of falls and death. Protein intake and vitamin D are important for the maintenance of muscle mass, and the amino acid leucine plays a role in the regulation of muscle protein turnover. The aim of this 12-week double-blind, randomised, placebo-controlled trial was to evaluate the efficacy of a supplement containing protein, vitamin D, leucine and calcium for maintaining muscle mass, strength and physical functioning in healthy Koreans aged 50-80 years. Increases in muscle mass were seen in those with low vitamin D levels (< 30 ng/ml) but not in those with higher vitamin D levels. No differences were observed in muscle strength and physical functioning. The authors concluded that a supplement containing protein, including high levels of leucine, vitamin D and calcium may be of benefit for muscle mass to middle-aged and older adults with low vitamin D levels.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Consider supplementing protein in combination with leucine, vitamin D and calcium in middle-aged or older adults with insufficient vitamin D levels for prevention of sarcopenia.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- Sarcopenia increases the risk of falls and death
- Protein and vitamin D are important for maintaining muscle mass whilst leucine is involved in regulating muscle protein turnover
- The aim of this study was to evaluate the effects of a supplement containing protein, vitamin D, leucine and calcium on muscle mass, physical functioning, muscle strength, and physical ability in middle-aged and older adults.
Methods
- Double-blind, randomised, placebo-controlled trial, with a duration of 12 weeks. Included 120 healthy Koreans aged 50-80 years
- Participants were assigned to “insufficient” subgroup if vitamin D levels were <30ng/ml and to the “sufficient” subgroup if vitamin D was 30ng/ml or higher
- Intervention: 2.5g powder (containing 20g protein (90% milk/10% soya, incl. 3g leucine), 800 IU vitamin D, 300 mg calcium) mixed into beverage of choice twice a day. Control: isocaloric placebo powder
- Primary outcome: Muscle mass determined by dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA)
- Secondary outcomes: Muscle strength (femoral muscle and grip strength); physical functioning (short physical performance battery (SPPB), International Physical Activity Questionnaire (IPAQ)).
Results
- At baseline, age of participants in the “sufficient” intervention subgroup was higher than that of the “sufficient” control subgroup (p=0.02)
- Increase in vitamin D levels in intervention group relative to control group, in both sufficient and insufficient subgroups (difference in changes between groups 11.5 ng/ml and 13.9 ng/ml, respectively, both p=0.00)
- No difference in change in muscle index as measured by DXA between groups
- In the “insufficient” subgroup, BIA increases in muscle mass were seen when normalised by height (p=0.037) and weight (p=0.05)
- No differences in changes in physical functioning or muscle strength between groups.
Conclusion
- The authors conclude that a supplement containing protein, with high levels of leucine, vitamin D and calcium may be of benefit for muscle mass to middle-aged and older adults with insufficient vitamin D levels.
Clinical practice applications:
- Middle-aged and older adults with insufficient vitamin D levels may gain muscle mass through supplementation of protein, leucine, vitamin D and calcium
- Middle-age and older adults with sufficient vitamin D levels do not appear to benefit from the same intervention.
Considerations for future research:
- Longer-term studies may help identify whether increases in muscle mass lead to improved physical functioning over time
- A study combining supplementation and exercise may help identify additive or synergistic effects.
Abstract
UNLABELLED Early prevention of sarcopenia can be an important strategy for muscle maintenance, but most studies target subjects at slightly pre-sarcopenic state. Our previous paper describes the effect of protein supplements rich in leucine and vitamin D on muscle condition, and in this paper, we performed a sub-analysis to evaluate who benefitted the most in terms of improvement in muscle health. A 12-week randomized clinical trial of 120 healthy adults (aged 50 to 80) assigned to an intervention group (n = 60) or control group (n = 60) were analyzed. Subjects in the intervention group received, twice per day, a protein supplement containing (per serving) 800 IU of vitamin D, 20 g of protein (3 g of total leucine), 300 mg of calcium, 1.1 g of fat, and 2.5 g of carbohydrate. The subjects were classified into 'insufficient' and 'sufficient' groups at 25-hydroxyvitamin D (25[OH]D) value of 30 ng/mL. The skeletal muscle mass index normalized to the square of the skeletal muscle mass (SMM) height (kg/m2) increased significantly in the 'insufficient group' difference value of change between weeks 0 and 12 (Δ1.07 ± 2.20; p = 0.037). The SMM normalized by body weight (kg/kg, %) was higher, but not significantly, in the insufficient group (Δ0.38 ± 0.69; p = 0.050). For people with insufficient (serum 25[OH]D), supplemental intake of protein and vitamin D, calcium, and leucine and adequate energy intake increases muscle mass in middle-aged and older adults and would be likely to exert a beneficial effect on muscle health. TRIAL REGISTRATION Clinical Research Information Service Identifier: KCT0005111.
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Effect of Vitamin D3 Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double-Blind Controlled Trial.
Slobogean, GP, Bzovsky, S, O'Hara, NN, Marchand, LS, Hannan, ZD, Demyanovich, HK, Connelly, DW, Adachi, JD, Thabane, L, Sprague, S
JBMR plus. 2023;7(1):e10705
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Almost half of all adult patients with fractures are vitamin D deficient. The aim of this double-blind, randomised, placebo-controlled trial was to evaluate the efficacy of different vitamin D regimens on the healing of acute tibia and femur fractures. 102 18-50-year-old patients were enrolled in the study and randomised to receive a) two high doses (150,000 IU) at time of injury and after 6 weeks, b) 4000 IU daily, c) 600 IU daily or d) placebo for 3 months. After 3 months, there were no statistically significant differences between the 3 intervention groups with respect to clinical or radiographic outcomes of fracture healing. The authors report a significantly better clinical, but not radiographic, outcome for 4000 IU per day versus placebo with a p-value of 0.15 (note: generally, to be considered statistically significant, p should be < 0.05). Similar results were observed after 12 months. There was no significant correlation between vitamin D levels and fracture healing. The authors concluded that high dose vitamin D may confer a modest benefit for fracture healing but that this requires confirmation from a larger clinical trial.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The evidence base for the use of vitamin D supplements in isolation to support fracture healing is weak.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- Low levels of vitamin D can have negative effects on bone metabolism and healing of fractures
- Almost half of all adult fracture patients are vitamin D deficient
- The aim of this study was to evaluate the effectiveness of supplementing vitamin D3 (VD3) to improve tibia and femur fracture healing.
Methods
- Four-arm, double-blind, randomised, phase II screening, placebo-controlled trial
- 102 adult patients (aged 18-50 years) with a non-osteoporotic tibial or femoral shaft fracture were randomised into 1 of 4 treatment groups
- Just over half (56%) of participants were vitamin D3 deficient at baseline
- Intervention groups: 1) 150,000 IU VD3 loading dose at injury and at 6 weeks (high loading) plus daily placebo; 2) placebo loading doses plus 4000 IU VD3 daily (high dose); 3) placebo loading doses plus 600 IU VD3 daily (low dose); 4) placebo loading dose plus placebo daily
- Duration: 3 months intervention, further 9 months follow-up. Vitamin D levels were assessed at 6 weeks and 3 months.
Primary outcome measures at 3 months:
- Clinical assessment using the Function IndeX for Trauma (FIX-IT)
- Radiographic assessment using the Radiographic Union Score for Tibial fractures (RUST).
Secondary outcomes: as above at 6, 9 and 12 months.
Results at 3 months:
- No statistically significant difference between high loading and high dose, high and low dose or low dose and placebo for either clinical or radiological assessment (all p-values ≥0.4)
- Post-hoc analysis of any dose vs placebo showed no significant difference with either clinical or radiological assessment (all p-values ≥0.25)
- Post-hoc analysis of high dose vs placebo showed no significant difference for radiological assessment (p=0.76) whilst it was reported as statistically significant for clinical assessment with p=0.16, with a benefit of VD3 supplementation.
- Similar results were seen at 12 months with reported benefit of high dose VD3 for fracture healing with p=0.18
- Vitamin D levels improved in all 3 VD3 groups from baseline to 6 weeks
- There was no statistically significant correlation between fracture healing and vitamin D level.
Conclusion
The authors conclude that VD3 supplementation may be of modest benefit for fracture healing, but further, larger trials are needed to confirm this.
Clinical practice applications:
- When working with clients who present with a fracture, it should be noted that the evidence for benefit of vitamin D supplementation alone for fracture healing is weak.
Considerations for future research:
- Larger studies to increase the statistical power to detect smaller benefits are required
- Larger studies may also identify differences in potential benefits between patient populations with different baseline levels of vitamin D.
Abstract
Nearly half of adult fracture patients are vitamin D deficient (serum 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Many surgeons advocate prescribing vitamin D supplements to improve fracture healing outcomes; however, data supporting the effectiveness of vitamin D3 supplements to improve acute fracture healing are lacking. We tested the effectiveness of vitamin D3 supplementation for improving tibia and femur fracture healing. We conducted a single-center, double-blinded phase II screening randomized controlled trial with a 12-month follow-up. Patients aged 18-50 years receiving an intramedullary nail for a tibia or femoral shaft fracture were randomized 1:1:1:1 to receive (i) 150,000 IU loading dose vitamin D3 at injury and 6 weeks (n = 27); (ii) 4000 IU vitamin D3 daily (n = 24); (iii) 600 IU vitamin D3 daily (n = 24); or (iv) placebo (n = 27). Primary outcomes were clinical fracture healing (Function IndeX for Trauma [FIX-IT]) and radiographic fracture healing (Radiographic Union Score for Tibial fractures [RUST]) at 3 months. One hundred two patients with a mean age of 29 years (standard deviation 8) were randomized. The majority were male (69%), and 56% were vitamin D3 deficient at baseline. Ninety-nine patients completed the 3-month follow-up. In our prespecified comparisons, no clinically important or statistically significant differences were detected in RUST or FIX-IT scores between groups when measured at 3 months and over 12 months. However, in a post hoc comparison, high doses of vitamin D3 were associated with improved clinical fracture healing relative to placebo at 3 months (mean difference [MD] 0.90, 80% confidence interval [CI], 0.08 to 1.79; p = 0.16) and within 12 months (MD 0.89, 80% CI, 0.05 to 1.74; p = 0.18). The study was designed to identify potential evidence to support the effectiveness of vitamin D3 supplementation in improving acute fracture healing. Vitamin D3 supplementation, particularly high doses, might modestly improve acute tibia or femoral shaft fracture healing in healthy adults, but confirmatory studies are required. The Vita-Shock trial was awarded the Orthopaedic Trauma Association's (OTA) Bovill Award in 2020. This award is presented annually to the authors of the most outstanding OTA Annual Meeting scientific paper. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
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Effect of vitamin D supplementation on cardiac-metabolic risk factors in elderly: a systematic review and meta-analysis of clinical trials.
Qorbani, M, Zarei, M, Moradi, Y, Appannah, G, Djalainia, S, Pourrostami, K, Ejtahed, HS, Mahdavi-Gorabi, A, Naderali, EK, Khazdouz, M
Diabetology & metabolic syndrome. 2022;14(1):88
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Modifiable risk factors such as dyslipidemia, hyperglycemia, obesity, and hypertension are characteristics of cardio-metabolic disorder which may lead to diabetes or cardiovascular disease. Previous research has shown an association between vitamin D deficiency and cardio-metabolic disorders. Studies have also shown that vitamin D deficiency is prevalent in older people. Therefore, this systematic review and meta-analysis evaluated the beneficial effects of Vitamin D supplementation (VDS) on the cardio-metabolic profile in elderly people. Twelve studies are included in this systematic review and meta-analysis. VDS dosage ranged from 400 IU/day to 4000 IU/day generally in most of the included studies, and the duration of intervention ranged from two months to one year. This systematic review and meta-analysis showed an improvement in total cholesterol and triglycerides followed by VDS in elderly participants. The subgroup analysis revealed improved glycaemic indices in elderly people with glycaemic irregularities. Longer-term VDS intervention improved glycaemic control. Further robust studies are required as there is high heterogeneity in the form of the vitamin D, dosage, duration, route of administration and study design of the included studies in this research. However, healthcare professionals can use the results of this study to understand the therapeutic value of VDS in improving the cardio-metabolic health of elderly people.
Abstract
BACKGROUND There has been a longstanding interest in the potential effect of vitamin D in preventing cardiac-metabolic diseases. However, there are divergent results regarding the impact of vitamin D supplementation (VDS) on managing cardiac-metabolic outcomes in the elderly population. MATERIAL AND METHOD We systematically searched electronic databases; Web of Science, PubMed, Scopus, EMBASE, Cochrane, and ProQuest. We included all trials that evaluated the effect of VDS on cardiac-metabolic risk factors in the elderly population, which were published until 30 September 2021. The effects of VDS on cardiac-metabolic outcomes were assessed using standardized mean difference (SMD). A random-effect model was used to pool the SMD and 95% confidence interval (CI). RESULT The literature search identified 4409 studies, of which 12 trials met inclusion criteria. Results of random effect meta-analysis indicated a significant reduction in total cholesterol (TC) (SMD: - 0.14 mg/dl; 95% CI: - 0.25, - 0.02) and triglyceride (TG) (SMD: - 0.45 mg/dl; 95% CI: - 0.86, - 0.04) with VDS compared to the placebo. The subgroup analyses revealed that the reduction of TG in patients with diabetes and vitamin D deficiency was significant. Furthermore, short-term intervention (≤ 6 months) induced a significantly lower level of TG and insulin in comparison to longer duration (> 6 months). CONCLUSION The study suggests that VDS could improve insulin concentration and dyslipidemia in the elderly population. The systematic review was registered in Alborz university of medical sciences with 2060-01-03-1397 number and the Ethics council IR.ABZUMS.REC.1397.207 number.
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Vitamin D Supplementation and Physical Activity of Young Soccer Players during High-Intensity Training.
Skalska, M, Nikolaidis, PT, Knechtle, B, Rosemann, TJ, Radzimiński, Ł, Jastrzębska, J, Kaczmarczyk, M, Myśliwiec, A, Dragos, P, López-Sánchez, GF, et al
Nutrients. 2019;11(2)
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It has been shown that the vitamin D levels in athletes has a significant impact on their neuro-muscular system. The aim of this study was to determine the effect of vitamin D supplementation on physical activity measures among soccer players during small-sided games after an 8-week high-intensity training programme. In this placebo-controlled, double blind study, 36 participants were randomised to receive either placebo or vitamin D (5000 IU) supplementation for 8 weeks. Average distance and intensity was calculated based on four small-sided games. While the supplemented group increased vitamin D levels significantly, improvements in various physical activity measures were not statistically significant. Though the effect size of this trial is low the authors recommend supplementing vitamin D to young soccer players, especially with vitamin D levels are deficient.
Abstract
The aim of this study was to confirm that vitamin D supplementation of young soccer players during eight-week high-intensity training would have a significant effect on their motion activity. The subjects were divided into two groups: the experimental one, which was supplemented with vitamin D (SG, n = 20), and the placebo group (PG, n = 16), which was not supplemented with vitamin D. All the players were subjected to the same soccer training, described as High-Intensity Interval Training (HIIT). The data of the vitamin D status, time motion parameters and heart rate were collected just before and after the intervention. A significant increase in 25(OH)D concentration (119%) was observed in the supplemented group, while the non-supplemented group showed a decrease of 8.4%. Based on the obtained results, it was found that physical activity indicators in the players were significantly improved during small-sided games at the last stage of the experiment. However, taking into account the effect of supplementation with vitamin D, there were no statistically significant differences between the placebo and the supplemented groups; thus, the effect size of the conducted experiment was trivial.
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Effects of Vitamin D Supplementation During Pregnancy on Birth Size: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Maugeri, A, Barchitta, M, Blanco, I, Agodi, A
Nutrients. 2019;11(2)
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Vitamin D deficiency may affect mother and neonatal outcomes, increasing the risk of pregnancy complications, preterm birth, low birth weight (LBW), small for gestational age (SGA), and poor offspring health. This systematic review and meta-analysis evaluates the effects of oral vitamin D supplementation during pregnancy on foetal growth and incidence of LBW and SGA births. 13 randomised controlled trials (RCTs), published between 1980 and 2016, were included in the meta-analysis, including in total 2016 newborns (1184 from mothers in the intervention groups and 832 from controls). Dosages ranged from 200-4000 IU for daily intakes and 35000 IU to 600000 IU for single or intermittent administration. Whilst there was no evidence for publication bias (e.g. an over-reporting of positive outcomes), overall, the quality of the reviewed studies varied from very low (head circumference) to moderate (birth weight, birth length, LBW, and SGA). All studies evaluating the effect of vitamin D supplementation on blood 25-hydroxyvitamin D (OHD) levels showed that intervention significantly increased 25-OHD concentration in both mothers and infants. The meta-analysis showed that vitamin D supplementation significantly increased birth weight and length, independent of dosage and whether vitamin D was administered daily or in single/intermittent high dosages. Head circumference was increased in a non-dose dependent way with daily but not with single/intermittent vitamin D supplementation. Effects on all three parameters were seen when vitamin D was supplemented alone, but not in combination with other nutrients. Both, risk of LBW and SGA, were also significantly reduced with vitamin D supplementation.
Abstract
During pregnancy, vitamin D supplementation may be a feasible strategy to help prevent low birthweight (LBW) and small for gestational age (SGA) births. However, evidence from randomized controlled trials (RCTs) is inconclusive, probably due to heterogeneity in study design and type of intervention. A systematic literature search in the PubMed-Medline, EMBASE, and Cochrane Central Register of Controlled Trials databases was carried out to evaluate the effects of oral vitamin D supplementation during pregnancy on birthweight, birth length, head circumference, LBW, and SGA. The fixed-effects or random-effects models were used to calculate mean difference (MD), risk ratio (RR), and 95% Confidence Interval (CI). On a total of 13 RCTs, maternal vitamin D supplementation had a positive effect on birthweight (12 RCTs; MD = 103.17 g, 95% CI 62.29⁻144.04 g), length (6 RCTs; MD = 0.22 cm, 95% CI 0.11⁻0.33 cm), and head circumference (6 RCTs; MD:0.19 cm, 95% CI 0.13⁻0.24 cm). In line with these findings, we also demonstrated that maternal vitamin D supplementation reduced the risk of LBW (3 RCTs; RR = 0.40, 95% CI 0.22⁻0.74) and SGA (5 RCTS; RR = 0.69, 95% CI 0.51⁻0.92). The present systematic review and meta-analysis confirmed the well-established effect of maternal vitamin D supplementation on birth size. However, further research is required to better define risks and benefits associated with such interventions and the potential implications for public health.
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Low free 25-hydroxyvitamin D and high vitamin D binding protein and parathyroid hormone in obese Caucasians. A complex association with bone?
Saarnio, E, Pekkinen, M, Itkonen, ST, Kemi, V, Karp, H, Ivaska, KK, Risteli, J, Koivula, MK, Kärkkäinen, M, Mäkitie, O, et al
PloS one. 2018;13(2):e0192596
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Obese people are at a higher risk of vitamin D deficiency, and this could have an impact on bone mineral density. This study examined whether there were any differences between obese, overweight and normal-weight adults in levels of vitamin D, vitamin D binding protein (DBP), parathyroid hormone (PTH) and bone density. More than 500 healthy Finnish men and women aged 37-47 years took part in the study. Vitamin D levels were found to be lower in obese than in normal weight people. Levels of DBP and PTH were higher in obese than normal weight women. Some measures of bone density were higher in obese women. Markers of bone turnover were lower in obese people than those of normal weight. The findings of this study suggest that obese people may differ from normal weight subjects in vitamin D metabolism. It is not yet clear what impact this has on bone health.
Abstract
BACKGROUND Studies have shown altered vitamin D metabolism in obesity. We assessed differences between obese and normal-weight subjects in total, free, and bioavailable 25-hydroxyvitamin D (25(OH)D, 25(OH)DFree, and 25(OH)DBio, respectively), vitamin D binding protein (DBP), parathyroid hormone (PTH) and bone traits. METHODS 595 37-47-year-old healthy Finnish men and women stratified by BMI were examined in this cross-sectional study. Background characteristic and intakes of vitamin D and calcium were collected. The concentrations of 25(OH)D, PTH, DBP, albumin and bone turnover markers were determined from blood. 25(OH)DFree and 25(OH)DBio were calculated. pQCT was performed at radius and tibia. RESULTS Mean±SE (ANCOVA) 25(OH)DFree (10.8±0.6 vs 12.9±0.4 nmol/L; P = 0.008) and 25(OH)DBio (4.1±0.3 vs 5.1±0.1 nmol/L; P = 0.003) were lower in obese than in normal-weight women. In men, 25(OH)D (48.0±2.4 vs 56.4±2.0 nmol/L, P = 0.003), 25(OH)DFree (10.3±0.7 vs 12.5±0.6 pmol/L; P = 0.044) and 25(OH)DBio (4.2±0.3 vs 5.1±0.2 nmol/L; P = 0.032) were lower in obese. Similarly in all subjects, 25(OH)D, 25(OH)DFree and 25(OH)DBio were lower in obese (P<0.001). DBP (399±12 vs 356±7mg/L, P = 0.008) and PTH (62.2±3.0 vs 53.3±1.9 ng/L; P = 0.045) were higher in obese than in normal-weight women. In all subjects, PTH and DBP were higher in obese (P = 0.047and P = 0.004, respectively). In obese women, 25(OH)D was negatively associated with distal radius trabecular density (R2 = 0.089, P = 0.009) and tibial shaft cortical strength index (CSI) (R2 = 0.146, P = 0.004). 25(OH)DFree was negatively associated with distal radius CSI (R2 = 0.070, P = 0.049), radial shaft cortical density (CorD) (R2 = 0.050, P = 0.045), and tibial shaft CSI (R2 = 0.113, P = 0.012). 25(OH)DBio was negatively associated with distal radius CSI (R2 = 0.072, P = 0.045), radial shaft CorD (R2 = 0.059, P = 0.032), and tibial shaft CSI (R2 = 0.093, P = 0.024). CONCLUSIONS The associations between BMI and 25(OH)D, 25(OH)DFree, and 25(OH)DBio, DBP, and PTH suggest that obese subjects may differ from normal-weight subjects in vitamin D metabolism. BMI associated positively with trabecular bone traits and CSI in our study, and slightly negatively with cortical bone traits. Surprisingly, there was a negative association of free and bioavailable 25(OH)D and some of the bone traits in obese women.
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A randomized, double-blind study to assess if vitamin D treatment affects the outcomes of rehabilitation and balance in hemiplegic patients.
Sari, A, Durmus, B, Karaman, CA, Ogut, E, Aktas, I
Journal of physical therapy science. 2018;30(6):874-878
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Following a stroke, many patients are left with muscle weakness or paralysis down one side of the body, which can lead to problems with movement and balance. This study aimed to investigate the effect of vitamin D supplements on the recovery of stroke patients with vitamin D deficiency. At the beginning of the study, patients were given injections of either 300,000 IU vitamin D or saline (control), into their muscles. They then received three months of rehabilitation. By the end of the third month, the vitamin D group saw significantly better improvements in balance, fall risk, daily activities and mobility than the control group. Ability to walk unassisted and motor function were not significantly different between the two groups. The study concluded that vitamin D supplementation has positive effects on the improvement of balance and activities of daily living in stroke patients who have low levels of vitamin D.
Abstract
[Purpose] To investigate the effect of vitamin D supplementation on rehabilitation outcomes and balance in patients having hemiplegia due to ischemic stroke. [Subjects and Methods] Vitamin D levels of 132 patients hospitalized for hemiplegia rehabilitation due to ischemic stroke were tested. Consequently, 86/132 patients had low vitamin D levels, 72 of which met the inclusion criteria and were included in the study. Patients were divided into two groups: Group A (injected with 300,000 IU vitamin D), and Group B (injected intramuscularly with saline). Each patient was tested at the baseline and at the third month using the Brunnstrom recovery staging, functional ambulation scale, modified Barthel index, and Berg balance scale. The findings were compared between the groups. [Results] By the end of the third month, The Berg balance scale results and modified Barthel index scores significantly differed between the two groups, whereas Brunnstrom recovery staging and functional ambulation scale test results did not. [Conclusion] This study found that vitamin D administration increased the activity levels and accelerated balance recovery but did not significantly affect ambulation or motor recovery. These results warrant confirmation by longer follow-up studies with a larger number of participants.
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Vitamin D Supplementation in Pregnancy and Lactation and Infant Growth.
Roth, DE, Morris, SK, Zlotkin, S, Gernand, AD, Ahmed, T, Shanta, SS, Papp, E, Korsiak, J, Shi, J, Islam, MM, et al
The New England journal of medicine. 2018;379(6):535-546
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In Bangladesh, 30% of newborns are small for gestational age and 36% of children under 5-years of age have stunted growth. Some previous studies suggest that supplementing mums-to-be with vitamin D during and/or after pregnancy may improve foetal and infant growth. The aim of this trial was to evaluate the dose-dependent effects of vitamin D supplementation on infant growth in Bangladesh. Over 1,100 pregnant women were split into five groups. One group received no vitamin D (placebo group). Three groups received supplementation from mid pregnancy in doses of 4200 IU, 16,800 IU, and 28,000 IU per week. The fifth group received 28,000 IU vitamin D per week during pregnancy, as well as 28,000 IU weekly for 26 weeks after childbirth. At the start of the study, 64% of women were vitamin D deficient (defined as 25(OH)D<30 nmol/L). The vitamin D status of the women was similar across the groups. Among 1,164 infants assessed at 1 year of age, there were no significant differences across groups in the length-for-age scores. Other anthropometric measures, birth outcomes, and morbidity did not differ significantly across groups. The researchers concluded that maternal vitamin D supplementation from mid pregnancy until birth or until 6 months post-partum did not improve foetal or infant growth. The findings of the study do not support routine vitamin D supplementation in pregnancy or lactation to improve birth outcomes or infant growth, even in communities with endemic vitamin D deficiency and foetal-infant growth restriction.
Abstract
BACKGROUND It is unclear whether maternal vitamin D supplementation during pregnancy and lactation improves fetal and infant growth in regions where vitamin D deficiency is common. METHODS We conducted a randomized, double-blind, placebo-controlled trial in Bangladesh to assess the effects of weekly prenatal vitamin D supplementation (from 17 to 24 weeks of gestation until birth) and postpartum vitamin D supplementation on the primary outcome of infants' length-for-age z scores at 1 year according to World Health Organization (WHO) child growth standards. One group received neither prenatal nor postpartum vitamin D (placebo group). Three groups received prenatal supplementation only, in doses of 4200 IU (prenatal 4200 group), 16,800 IU (prenatal 16,800 group), and 28,000 IU (prenatal 28,000 group). The fifth group received prenatal supplementation as well as 26 weeks of postpartum supplementation in the amount of 28,000 IU (prenatal and postpartum 28,000 group). RESULTS Among 1164 infants assessed at 1 year of age (89.5% of 1300 pregnancies), there were no significant differences across groups in the mean (±SD) length-for-age z scores. Scores were as follows: placebo, -0.93±1.05; prenatal 4200, -1.11±1.12; prenatal 16,800, -0.97±0.97; prenatal 28,000, -1.06±1.07; and prenatal and postpartum 28,000, -0.94±1.00 (P=0.23 for a global test of differences across groups). Other anthropometric measures, birth outcomes, and morbidity did not differ significantly across groups. Vitamin D supplementation had expected effects on maternal and infant serum 25-hydroxyvitamin D and calcium concentrations, maternal urinary calcium excretion, and maternal parathyroid hormone concentrations. There were no significant differences in the frequencies of adverse events across groups, with the exception of a higher rate of possible hypercalciuria among the women receiving the highest dose. CONCLUSIONS In a population with widespread prenatal vitamin D deficiency and fetal and infant growth restriction, maternal vitamin D supplementation from midpregnancy until birth or until 6 months post partum did not improve fetal or infant growth. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT01924013 .).
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Association Between Single Gene Polymorphisms and Bone Biomarkers and Response to Calcium and Vitamin D Supplementation in Young Adults Undergoing Military Training.
Gaffney-Stomberg, E, Lutz, LJ, Shcherbina, A, Ricke, DO, Petrovick, M, Cropper, TL, Cable, SJ, McClung, JP
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2017;32(3):498-507
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The risk of stress fracture is increased in initial military training (IMT) largely because of unaccustomed activity, resulting in a change in calcium and vitamin D levels. Genetic polymorphisms are variations in a gene that affect the level of gene expression, and bone metabolism and absorption is impacted by this. The primary aim of this randomised, double-blind, placebo controlled trial was to determine whether genes related to Calcium and vitamin D were associated with markers of bone metabolism in 748 young adults entering military training. Participants were randomised to consume bars between meals that were either supplemented with Calcium and vitamin D or placebo that were matched in taste and appearance. Fasting blood samples were taken before and after the 7- to 9-week IMT programme to assess circulating biomarkers and genes. This study found that genetic polymorphisms related to Calcium and vitamin D were associated with vitamin D status and markers of bone metabolism. It also found that genes could predict change in vitamin D absorption levels. Based on these results, the authors conclude this study provides novel insight that helps further understanding between genetics, environment and bone metabolism.
Abstract
Initial military training (IMT) is associated with increased stress fracture risk. In prior studies, supplemental calcium (Ca) and vitamin D provided daily throughout IMT reduced stress fracture incidence, suppressed parathyroid hormone (PTH), and improved measures of bone health compared with placebo. Data were analyzed from a randomized, double-blind, placebo-controlled trial to determine whether single-nucleotide polymorphisms (SNPs) in Ca and vitamin D-related genes were associated with circulating biomarkers of bone metabolism in young adults entering IMT, and whether responses to Ca and vitamin D supplementation were modulated by genotype. Associations between SNPs, including vitamin D receptor (VDR), vitamin D binding protein (DBP), and 1-alpha-hydroxylase (CYP27B1), and circulating biomarkers were measured in fasting blood samples from volunteers (n = 748) starting IMT. Volunteers were block randomized by race and sex to receive Ca (2000 mg) and vitamin D (1000 IU) or placebo daily throughout Army or Air Force IMT (7 to 9 weeks). Total Ca and vitamin D intakes were calculated as the sum of supplemental intake based on intervention compliance and dietary intake. Relationships between SNPs, Ca, and vitamin D intake tertile and change in biomarkers were evaluated in trial completers (n = 391). At baseline, the minor allele of a DBP SNP (rs7041) was positively associated with both 25OHD (B = 4.46, p = 1.97E-10) and 1,25(OH)2 D3 (B = 9.63, p < 0.001). Combined genetic risk score (GRS) for this SNP and a second SNP in the VDR gene (rs1544410) was inversely associated with baseline 25OHD (r = -0.28, p < 0.001) and response to Ca and vitamin D intake differed by GRS (p < 0.05). In addition, presence of the minor allele of a second VDR SNP (rs2228570) was associated with lower P1NP (B = -4.83, p = 0.04) and osteocalcin (B = -0.59, p = 0.03). These data suggest that VDR and DBP SNPs are associated with 25OHD status and bone turnover and those with the highest GRS require the greatest vitamin D intake to improve 25OHD during IMT. © 2016 American Society for Bone and Mineral Research.
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The association of calcium and vitamin D with risk of colorectal adenomas.
Hartman, TJ, Albert, PS, Snyder, K, Slattery, ML, Caan, B, Paskett, E, Iber, F, Kikendall, JW, Marshall, J, Shike, M, et al
The Journal of nutrition. 2005;135(2):252-9
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Plain language summary
Calcium and vitamin D may play a role in colorectal cancer incidence. One possible explanation is that they may act synergistically on a number of mechanisms to protect against recurrence of colonic adenomas. The aim of the study was to determine the effects of a high-fibre, high-fruit and vegetable, and low-fat diet on the recurrence of adenomatous polyps in the large bowel. For the present study, 1905 participants from the 2079 Polyp Prevention Trial participants who completed the full trial follow-up were evaluated. The participants’ diet was assessed at baseline and annually, and they also received full colonoscopies at baseline, their 1-year visit and at the end of the trial i.e. 4 years after randomization. Results show that there were no significant associations between any of the adenoma recurrence outcome variables and dietary or total calcium intake, consumption of low or high-fat dairy products or dietary vitamin D intake. However, total vitamin D intake was weakly inversely associated with adenoma recurrence. Calcium and vitamin D supplementation were also inversely associated with single and multiple adenoma recurrence. The study shows that calcium and vitamin D intake may provide weakly protective associations with the risk for recurrence of adenoma polyps.
Abstract
The Polyp Prevention Trial (PPT) was a multicenter randomized clinical trial designed to determine the effects of a high-fiber, high-fruit and vegetable, low-fat diet on the recurrence of adenomatous polyps in the large bowel. Detailed dietary intake and supplement use data were collected at baseline and at each of 4 annual study visits. Adenoma recurrence was ascertained by complete colonoscopy at baseline and after 1 and 4 y. Recurrence was found in 754 of the 1905 trial participants. We evaluated the association between calcium and vitamin D intake and adenomatous polyp recurrence after adjusting for intervention group, age, gender, nonsteroidal anti-inflammatory drug use, total energy intake, and the interaction of gender and intervention group. Vitamin D models were also adjusted for the location of the clinic site. Dietary variables were adjusted for total energy intake via the residual method. There were no overall significant associations between adenoma recurrence and dietary calcium intake [odds ratio (OR) for the 5th compared with the lowest quintile = 0.91; 95% CI = 0.67-1.23; P-trend = 0.68], total calcium intake (OR = 0.86; 95% CI = 0.62-1.18; P-trend = 0.20), or dietary vitamin D intake (OR = 0.93; 95% CI = 0.69-1.25; P-trend = 0.43) averaged over follow-up. Total vitamin D intake was weakly inversely associated with adenoma recurrence (OR = 0.84; 95% CI = 0.62-1.13; P-trend = 0.03). Supplemental calcium and vitamin D use during follow-up also were inversely associated with adenoma recurrence (OR for any compared with no use = 0.82; 95% CI = 0.68-0.99; and OR = 0.82; 95% CI = 0.68-0.99; for calcium and vitamin D, respectively). Slightly stronger associations were noted for the prevention of multiple recurrences. Our analyses did not suggest a significant effect modification between total calcium and total vitamin D intake (P = 0.14) on risk for adenoma recurrence. This trial cohort provides some evidence that calcium and vitamin D may be inversely associated with adenoma recurrence.