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Vitamin D supplementation and cardiometabolic risk factors among diverse schoolchildren: a randomized clinical trial.
Sacheck, JM, Huang, Q, Van Rompay, MI, Chomitz, VR, Economos, CD, Eliasziw, M, Gordon, CM, Goodman, E
The American journal of clinical nutrition. 2022;(1):73-82
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Abstract
BACKGROUND There remains a lack of evidence demonstrating a potential relationship between vitamin D and cardiometabolic risk among children. OBJECTIVES We examined the effect of 3 different dosages of vitamin D on cardiometabolic risk factors among children at risk of deficiency. METHODS Racially diverse schoolchildren aged 8-15 y were randomly assigned in a double-blind fashion to supplementation with 600, 1000, or 2000 IU vitamin D3/d for 6 mo. Changes in HDL cholesterol, triglycerides, LDL cholesterol, total cholesterol, and blood glucose over 6 mo and at 12 mo (6 mo post-supplementation) were assessed. Subgroup analyses were also performed by weight status and race. RESULTS Among 604 children, 40.9% were vitamin D-inadequate at baseline (<20 ng/mL; mean ± SD: 22.0 ± 6.8 ng/mL), 46.4% were overweight/obese, and 60.9% had ≥1 suboptimal blood lipids or glucose. Over 6 mo, serum 25-hydroxyvitamin D increased in all 3 dosage groups from baseline (mean ± SE change: 4.4 ± 0.6 ng/mL, 5.7 ± 0.7 ng/mL, and 10.7 ± 0.6 ng/mL for 600, 1000, and 2000 IU/d, respectively; P < 0.001). Whereas HDL cholesterol and triglycerides increased in the 600 IU group (P = 0.002 and P = 0.02, respectively), LDL cholesterol and total cholesterol decreased across dosage groups. At 6 mo post-supplementation, HDL cholesterol remained elevated in the 600 and 1000 IU groups ( P < 0.001 and P = 0.02, respectively) whereas triglycerides remained elevated in the 1000 and 2000 IU groups (P = 0.04 and P = 0.006, respectively). The suppression of LDL cholesterol and total cholesterol persisted in the 2000 IU group only (P = 0.04 and P < 0.001, respectively). There were no significant changes in blood glucose and similar responses were observed overall by weight status and racial groups across dosages. CONCLUSIONS Vitamin D supplementation demonstrated generally positive effects on HDL cholesterol, LDL cholesterol, and total cholesterol, especially at the lower dosage of 600 IU/d, with several significant changes persisting during the post-supplementation period. Increases in triglycerides across dosage groups may be due to natural changes during adolescence warranting further study.This trial was registered at clinicaltrials.gov as NCT01537809.
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Features of the 1st trimester of pregnancy course with severe deficiency of 25(OH)D.
Bakleicheva, M, Bespalova, O, Kovaleva, I
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2021;(sup1):49-53
Abstract
INTRODUCTION The course of physiological pregnancy is provided by many complementary factors. Thus, a deficiency in one of the links of the metabolic network contributes to the development of an imbalance in the work of the whole organism, which ensures the growth and development of the embryo from the first days of gestation. It has been demonstrated that vitamin D can act as an immune regulator during implantation, providing a protective effect in the entire period of pregnancy. OBJECTIVE The aim of this study is to assess the features of the course of pregnancy in patients with different levels of vitamin D in the blood in the first trimester. MATERIALS AND METHODS A prospective multicenter randomized study was conducted in the North-West region of the Russian Federation among 88 pregnant women in the first trimester of gestation (up to 13 weeks). All patients were divided into 3 groups depending on the initial level of vitamin D (group 1-14 women with a 25(OH)D < 10 ng/ml, group 2-62 pregnant women from 10 to 30 ng/ml, group 3-12 pregnant women with a vitamin D content >30 ng/ml). INTERVENTIONS Criteria of inclusion: pregnant women from 20 to 44 years of the first trimester of gestation (up to 13 weeks) with the studied level of vitamin D in the blood serum; singleton pregnancy; BMI ≤30 kg/m2; signing by the patient of informed consent for inclusion in the study group. MAIN OUTCOME MEASURES AND RESULTS In group 1, 86% of patients with severe vitamin D deficiency were diagnosed with threatened miscarriage, which is significantly higher than in group 3 (85.7% and 33.3%, χ2 = 7.490, p = .007). At the same time, retrochorial hematoma in group 1 occurred 3.5 times more often than in group 3 (57.1% and 16.67%, respectively, χ2 = 4.473, p = .035). Subsequently, every 4th woman from the group with vitamin D deficiency gave birth earlier than expected, which was not observed among patients from group 3 (25%, 0%, χ2 = 1.231, p = .268). CONCLUSION Prescribing cholecalciferol vitamin replacement therapy as part of complex preserving therapy for threatening miscarriage, followed by monitoring its blood level and deviating from normal parameters, contributing to a favorable course of pregnancy and improving perinatal outcomes.
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Maternal obesity and baseline vitamin D insufficiency alter the response to vitamin D supplementation: a double-blind, randomized trial in pregnant women.
Alhomaid, RM, Mulhern, MS, Strain, J, Laird, E, Healy, M, Parker, MJ, McCann, MT
The American journal of clinical nutrition. 2021;(3):1208-1218
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BACKGROUND The achievement of target 25-hydroxyvitamin D [25(OH)D] concentrations in pregnancy may be altered by maternal obesity. OBJECTIVE The authors examined the effects of maternal supplementation of 10 μg compared with 20 μg vitamin D3/d on maternal and umbilical cord 25(OH)D. The secondary aim was to investigate the influence of maternal BMI (in kg/m2) on the response of the primary outcomes. METHODS The authors performed a 2-arm parallel double-blind randomized trial with 240 pregnant women recruited throughout the year in Northern Ireland. Women were stratified by BMI to receive 10 or 20 µg vitamin D3/d from 12 gestational wk (GW) until delivery. Maternal blood samples collected at 12, 28, and 36 GW and from the umbilical cord were analyzed for total serum 25(OH)D. A total of 166 women completed the study. RESULTS Mean ± SD 25(OH)D at 36 GW was 80.8 ± 28.2 compared with 94.4 ± 33.2 nmol/L (P < 0.001) (10 compared with 20 µg vitamin D3/d, respectively). In those classified with 25(OH)D <50 nmol/L at baseline and assigned 10 µg vitamin D3/d, mean 25(OH)D concentrations remained <50 nmol/L at 36 GW, whereas those <50 nmol/L at baseline and assigned 20 µg vitamin D3/d, had mean 25(OH)D concentrations ≥50 nmol/L at 28 and 36 GW. In women with obesity and 25(OH)D <50 nmol/L at baseline, the related mean umbilical cord 25(OH)D was deficient (<25 nmol/L) in both treatment groups, whereas those with obesity and 25(OH)D ≥50 nmol/L at baseline had an average umbilical cord 25(OH)D between 25 and 50 nmol/L in both treatment groups. CONCLUSIONS Supplementation of 20 µg vitamin D3/d is needed to attain maternal and umbilical cord 25(OH)D concentrations ≥50 nmol/L on average, in those who start pregnancy with low 25(OH)D concentrations (<50 nmol/L). Under current recommendations, women with obesity and low 25(OH)D in early pregnancy are particularly vulnerable to maintaining a low 25(OH)D concentration throughout pregnancy and having an infant born with deficient 25(OH)D concentrations. This trial was registered at ClinicalTrials.gov as NCT02713009.
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Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial.
Naguib, SN, Sabry, NA, Farid, SF, Alansary, AM
Clinical therapeutics. 2021;(1):e1-e18
Abstract
PURPOSE Vitamin D deficiency is highly prevalent in critically ill patients, and has been associated with more prolonged length of hospital stay and poor prognosis. Patients undergoing open-heart surgery are at higher risk due to the associated life-threatening postoperative complications. This study investigated the effect of alfacalcidol treatment on the length of hospital stay in patients undergoing valve-replacement surgery. METHODS This single-center, randomized, open-label, controlled trial was conducted at El-Demerdash Cardiac Academy Hospital (Cairo, Egypt), from April 2017 to January 2018. This study included adult patients undergoing valve-replacement surgery who were randomized to the intervention group (n = 47; alfacalcidol 2 μg/d started 48 h before surgery and continued throughout the hospital stay) or to the control group (n = 42). The primary end points were lengths of stay (LOS) in the intensive care unit (ICU) and in the hospital. Secondary end points were the prevalence of postoperative hospital-acquired infections, cardiac complications, and in-hospital mortality. FINDINGS A total of 86 patients were included in the final analysis, with 51 (59.3%) being vitamin D deficient on hospital admission. Treatment with alfacalcidol was associated with a statistically significant decrease in ICU LOS (hazard ratio = 1.61; 95% CI, 1.77-2.81; P = 0.041) and hospital LOS (hazard ratio = 1.63; 95% CI, 1.04-2.55; P = 0.034). Treated patients had a significantly lower postoperative infection rate than did the control group (35.5% vs 56.1%; P = 0.017). The median epinephrine dose was lower in the intervention group compared to that in the control group (5.9 vs 8.2 mg; P = 0.019). The rate of in-hospital mortality was not significantly different between the 2 groups. IMPLICATIONS Early treatment with 2 μg of alfacalcidol in patients undergoing valve-replacement surgery is promising and well tolerated. This effect may be attributed to its immunomodulatory and cardioprotective mechanisms. ClinicalTrials.gov identifier: NCT04085770.
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Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial.
Andújar-Espinosa, R, Salinero-González, L, Illán-Gómez, F, Castilla-Martínez, M, Hu-Yang, C, Ruiz-López, FJ
Thorax. 2021;(2):126-133
Abstract
BACKGROUND The relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results. OBJECTIVE To evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma. METHODS Randomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D3 <30 ng/mL. The intervention group received oral supplementation with 16 000 IU of calcifediol per week, and the control group had placebo added to their usual asthma treatment. The study period was 6 months. The primary endpoint was the degree of asthma control as determined by the asthma control test (ACT). Secondary endpoints included quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma. RESULTS One hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (-0.57) (difference 3.66 (95% CI 0.89 to 5.43); p<0.001) as measured using ACT scores. Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01). CONCLUSION Among adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety. TRIAL REGISTRATION NUMBER NCT02805907.
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Association of serum 25-OH vitamin D₃ with serum IgE and the Pediatric Asthma Severity Score in patients with pediatric asthma.
Mohammadzadeh, I, Darvish, S, Qujeq, D, Hajiahmadi, M, Vaghari-Tabari, M
Allergy and asthma proceedings. 2020;(2):126-133
Abstract
Background: Pediatric asthma is a prevalent disease and has a significant immunologic and inflammatory nature. In recent years, the role of vitamin D₃ in immunologic processes has been studied, and many aspects of this role have been clarified in some human diseases. Objective: The aim of this study was to evaluate the relationship among the vitamin D₃ status, Pediatric Asthma Severity Score (PASS), and inflammatory indicators of pediatric asthma. Methods: Among all of the pediatric patients with asthma and with asthma exacerbation, 100 patients were randomly enrolled in the study and subdivided into three groups according to serum levels of 25-OH vitamin D₃. The control group consisted of 100 sex- and age-matched healthy subjects. Asthma exacerbation severity was evaluated based on the PASS before starting the medical care. The count of the white blood cells, eosinophil count, and serum levels of total immunoglobulin E (IgE) plus 25-OH vitamin D₃ were measured in all the subjects. The obtained data were then compared via proper statistical tests. A p value of <0.05 was considered as statistically significant. Results: The median level of serum IgE was increased in patients with vitamin D₃ deficiency compared with other groups. There was a significant inverse correlation between serum levels of 25-OH vitamin D₃ and IgE in pediatric patients with asthma (r = -0.483, p = 0.001). Furthermore, the serum levels of 25-OH vitamin D₃ also significantly inversely correlated with the PASS (r = -0.285, p = 0.004). Conclusion: Vitamin D₃ deficiency is associated with exacerbation severity and serum IgE levels in patients with pediatric asthma; hence, it can have an important role in pediatric asthma pathogenesis, possibly through IgE.
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Sunlight Exposure and Vitamin D Levels in Older People- An Intervention Study in Swedish Nursing Homes.
Samefors, M, Tengblad, A, Östgren, CJ
The journal of nutrition, health & aging. 2020;(10):1047-1052
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OBJECTIVES Older people are recommended to take oral vitamin D supplements, but the main source of vitamin D is sunlight. Our aim was to explore whether active encouragement to spend time outdoors could increase the levels of serum 25-hydroxyvitamin D (25(OH)D) and increase the mental well-being of nursing home residents. DESIGN A cluster randomized intervention trial. SETTING Nursing homes in southern Sweden. PARTICIPANTS In total 40 people >65 years. INTERVENTION The intervention group was encouraged to go outside for 20-30 minutes between 11 a.m. and 3 p.m. every day for two months during the summer of 2018. MEASUREMENTS We analyzed serum 25(OH)D before and after the summer. Data from SF-36 questionnaires measuring vitality and mental health were used for the analyses. RESULTS In the intervention group, the baseline median (interquartile range (IQR)) of serum 25(OH)D was 42.5 (23.0) nmol/l and in the control group it was 52.0 (36.0) nmol/l. In the intervention group, the 25(OH)D levels increased significantly during the summer (p=0.011). In the control group, there was no significant change. The intervention group reported better self-perceived mental health after the summer compared to before the summer (p=0.015). In the control group, there was no difference in mental health. CONCLUSION Active encouragement to spend time outdoors during summertime improved the levels of serum 25(OH)D and self-perceived mental health significantly in older people in nursing homes and could complement or replace oral vitamin D supplementation in the summer.
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The effect of intramuscular megadose of vitamin D injections on E-selectin, CRP and biochemical parameters in vitamin D-deficient patients with type-2 diabetes mellitus: A randomized controlled trial.
Mirzavandi, F, Talenezhad, N, Razmpoosh, E, Nadjarzadeh, A, Mozaffari-Khosravi, H
Complementary therapies in medicine. 2020;:102346
Abstract
BACKGROUND AND AIMS Inflammatory processes has been shown to be associated with the development of type 2 diabetes mellitus (T2DM) in which vitamin D supplementation might exert beneficial outcomes. We examined the effects of vitamin D supplement on inflammatory and cell adhesion molecule in patients with T2DM. METHODS This study consisted of 50 patients with T2DM who had vitamin D deficiency. Participants were randomized into two groups of 25 in which the intervention group received two intramuscular injections of a 200000-IU vitamin D supplement, one at week 0 and another at week 4. The concentrations of fasting blood glucose (FBG), lipid profiles, liver enzymes, E-selectin, C-reactive protein (CRP), calcium, phosphorus, serum 25-hydroxyvitamin D [25(OH)D] and anthropometric indices were obtained before and after 8 weeks. RESULTS Vitamin D resulted in significant reductions in CRP(P = 0.01) and gamma glutamyl transferase (GGT) levels(P = 0.03) and significant increases in 25(OH)D concentrations(P = 0.01) in the intervention group compared with the control. Within-group comparisons showed that FBG decreased significantly in the intervention group(P = 0.04). No significant changes were observed regarding within- and between-group comparisons of the other markers. CONCLUSION Vitamin D had beneficial effects on the levels of CRP, serum 25(OH)D and GGT among vitamin D deficient patients with T2DM. (http://www.irct.ir: IRCT2017100336539N1).
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Effectiveness of vitamin D supplementation in Swedish children may be negatively impacted by BMI and serum fructose.
McClorry, S, Slupsky, CM, Lind, T, Karlsland Åkeson, P, Hernell, O, Öhlund, I
The Journal of nutritional biochemistry. 2020;:108251
Abstract
In regions where sunlight exposure is limited, dietary vitamin D intake becomes important for maintaining status. However, Swedish children have been shown to have deficient or marginal status during the winter months even if the recommended dietary intake is met. Since low vitamin D status has been associated with several disease states, this study investigated the metabolic changes associated with improved vitamin D status due to supplementation. During the 3 winter months, 5-7-year-old children (n=170) in northern (Umeå, 63° N) and southern (Malmö, 55° N) Sweden were supplemented daily with 2 (placebo), 10 or 25 μg of vitamin D. BMI-for-age z-scores (BAZ), S-25(OH)D concentrations, insulin concentrations and the serum metabolome were assessed at baseline and follow-up. S-25(OH)D concentrations increased significantly in both supplementation groups (P<.001). Only arginine and isopropanol concentrations exhibited significant associations with improvements in S-25(OH)D. Furthermore, the extent to which S-25(OH)D increased was correlated with a combination of baseline BAZ and the change in serum fructose concentrations from baseline to follow up (P=.012). In particular, the change in S-25(OH)D concentrations was negatively correlated (P=.030) with the change in fructose concentrations for subjects with BAZ ≥0 and consuming at least 20 μg vitamin D daily. These results suggest that although the metabolic changes associated with improved vitamin D status are small, the effectiveness of dietary supplementation may be influenced by serum fructose concentrations.
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Vitamin D supplementation increases adipokine concentrations in overweight or obese adults.
Mousa, A, Naderpoor, N, Wilson, K, Plebanski, M, de Courten, MPJ, Scragg, R, de Courten, B
European journal of nutrition. 2020;(1):195-204
Abstract
PURPOSE Vitamin D regulates adipokine production in vitro; however, clinical trials have been inconclusive. We conducted secondary analyses of a randomized controlled trial to examine whether vitamin D supplementation improves adipokine concentrations in overweight/obese and vitamin D-deficient adults. METHODS Sixty-five individuals with a BMI ≥ 25 kg/m2 and 25-hydroxyvitamin D (25(OH)D) ≤ 50 nmol/L were randomized to oral cholecalciferol (100,000 IU single bolus followed by 4,000 IU daily) or matching placebo for 16 weeks. We measured BMI, waist-to-hip ratio, % body fat (dual X-ray absorptiometry), serum 25(OH)D (chemiluminescent immunoassay) and total adiponectin, leptin, resistin, and adipsin concentrations (multiplex assay; flow cytometry). Sun exposure, physical activity, and diet were assessed using questionnaires. RESULTS Fifty-four participants completed the study (35M/19F; mean age = 31.9 ± 8.5 years; BMI = 30.9 ± 4.4 kg/m2). After 16 weeks, vitamin D supplementation increased 25(OH)D concentrations compared with placebo (57.0 ± 21.3 versus 1.9 ± 15.1 nmol/L, p < 0.001). There were no differences between groups for changes in adiponectin, leptin, resistin, or adipsin in unadjusted analyses (all p > 0.05). After adjustment for baseline values, season, sun exposure, and dietary vitamin D intake, there was a greater increase in adiponectin (β[95%CI] = 13.7[2.0, 25.5], p = 0.02) and leptin (β[95%CI] = 22.3[3.8, 40.9], p = 0.02) in the vitamin D group compared with placebo. Results remained significant after additional adjustment for age, sex, and % body fat (p < 0.02). CONCLUSIONS Vitamin D may increase adiponectin and leptin concentrations in overweight/obese and vitamin D-deficient adults. Further studies are needed to clarify the molecular interactions between vitamin D and adipokines and the clinical implications of these interactions in the context of obesity. CLINICAL TRIAL REGISTRATION clinicaltrials.gov: NCT02112721.