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The effect of vitamin D supplementation on flow-mediated dilatation, oxidized LDL and intracellular adhesion molecule 1 on type 2 diabetic patients with hypertension: A randomized, placebo-controlled, double-blind trial.
Qasemi, R, Ghavamzadeh, S, Faghfouri, AH, Valizadeh, N, Mohammadi, A, Sayyadi, H
Diabetes & metabolic syndrome. 2021;(4):102200
Abstract
AIMS: Current study aimed to evaluate the effect of vitamin D supplementation on flow-mediated dilatation (FMD), oxidized LDL (oxLDL) and intracellular adhesion molecule 1 (ICAM1) in type 2 diabetic patients with hypertension. METHODS In a double-blinded, placebo-controlled trial, 44 patients were randomly divided into vitamin D group (2000 IU/d, n = 23) and placebo group (control, n = 21) for 12 weeks. Vascular function with FMD, Serum 25-OH vitamin D, oxLDL and ICAM1 were assessed at the baseline and after the intervention. This clinical trial was registered at Iranian Registry of Clinical Trials (IRCT20191223045861N1). RESULTS In intervention group serum level of vitamin D increased from 32.42 ± 10.56 to 40.45 ± 12.94 (p < 0.001). In the vitamin D group, oxLDL and ICAM1 significantly decreased and FMD increased significantly in both groups (p < 0.001). The level of oxLDL (p = 0.017) and ICAM1 (p < 0.001) were significantly lower in the vitamin D group than the placebo group and FMD (p < 0.001) was significantly higher in the vitamin D group. CONCLUSIONS Vitamin D supplementation of 2000 IU/d for 12 weeks can improve endothelial function and decrease ICAM1 and oxLDL in type 2 diabetic patients with hypertension.
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The Effects of Vitamin D Supplementation on Metabolic and Oxidative Stress Markers in Patients With Type 2 Diabetes: A 6-Month Follow Up Randomized Controlled Study.
Cojic, M, Kocic, R, Klisic, A, Kocic, G
Frontiers in endocrinology. 2021;:610893
Abstract
Vitamin D deficiency could play an important role in the pathogenesis of type 2 diabetes mellitus (T2DM) as it may alter several crucial processes in the development of diabetes and its complications, such as pancreatic insulin secretion, peripheral insulin resistance, persistence of systemic "sterile" inflammation and immune activation. Vitamin D may also have an antioxidant effect through the inhibition of free radicals generation. The reported study was designed with eligible consecutively recruited patients with T2DM on standard metformin therapy (n=130), randomized in 1:1 ratio, considered to have undergone Vitamin D supplementation according to the guidelines proposed by the Endocrine Society, or to have continued with metformin only. The potential benefit was monitored through the influence on glycemia level, glycated haemoglobin (HbA1c), insulin resistance index (calculated as homeostatic model assessment; HOMA-IR), Castelli Risk Index I and Tryglicerides/Thiobarbituric acid-reactive substances (TG/TBARS) Index in a 6-month follow up period. Our study indicates that oral daily doses of vitamin D improve HbA1c levels over the 3-month and 6-month period, followed by a significant decrease in advanced oxidation protein products levels over the 3-month period when higher vitamin D doses are given. The effect of vitamin D on HOMA-IR index, malondialdehyde levels and TG/TBARS index was not statistically significant. Further investigation should consider defining the doses of vitamin D in patients with T2DM which may attenuate the oxidative stress risk, the risk of metabolic syndrome and the risk of related cardiovascular events.
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The effects of consuming a low-fat yogurt fortified with nano encapsulated vitamin D on serum pro-oxidant-antioxidant balance (PAB) in adults with metabolic syndrome; a randomized control trial.
Taghizadeh, N, Sharifan, P, Ekhteraee Toosi, MS, Najar Sedgh Doust, F, Darroudi, S, Afshari, A, Rezaie, M, Safarian, M, Vatanparast, H, Eslami, S, et al
Diabetes & metabolic syndrome. 2021;(6):102332
Abstract
BACKGROUND AND AIM The current study aimed to assess the effect of fortified yogurt with nano-encapsulated vitamin D on serum pro-oxidant anti-oxidant balance (PAB) in adults with or without metabolic syndrome. METHODS In a quadruple blind clinical trial study, 139 adults with an age range of 30-50 years were randomly selected to receive either 1500 IU nano-encapsulated vitamin D fortified yogurt or placebo for ten weeks. Before and after the intervention period, blood sample was taken to determine the serum levels of vitamin D, pro-oxidant-antioxidant balance (PAB), and high-sensitivity C-reactive protein (hs-CRP). The laboratory tests were checked at baseline and at the end of the treatment. RESULTS Serum vitamin D increased significantly, from 14.47 ± 6.07 ng/mL to 21.39 ± 6.54 ng/mL (P < 0.001) after ten weeks in the intervention group. Serum hs-CRP and PAB were significantly lower following consumption period in intervention group [1.95(0.4-8.15) g/dL vs. 1.35(0.25-3.62) g/dL; P = 0.013] and (135.19 ± 42.4 HK vs. 115.39 ± 44.69) HK; P = 0.018] respectively. There were no significant differences between the intervention and control groups regarding weight and BMI at the end of the intervention period (p > 0.05). CONCLUSION Low-fat yogurt fortified with nano-encapsulated vitamin D was found to reduce serum PAB levels in adults with metabolic syndrome. PRACTICAL APPLICATION The findings of the present study indicated that a low-fat yogurt fortified with 1500 IU nano-encapsulated vitamin D for ten weeks, leads to a significant reduction in serum hs-CRP and PAB concentrations highlighted the anti-inflammatory/anti-oxidative effect of vitamin D.
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Effect of Vitamin D Supplementation on Outcomes in People With Early Psychosis: The DFEND Randomized Clinical Trial.
Gaughran, F, Stringer, D, Wojewodka, G, Landau, S, Smith, S, Gardner-Sood, P, Taylor, D, Jordan, H, Whiskey, E, Krivoy, A, et al
JAMA network open. 2021;(12):e2140858
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Abstract
IMPORTANCE People with psychotic disorders have an increased risk of vitamin D deficiency, which is evident during first-episode psychosis (FEP) and associated with unfavorable mental and physical health outcomes. OBJECTIVE To examine whether vitamin D supplementation contributes to improved clinical outcomes in FEP. DESIGN, SETTING, AND PARTICIPANTS This multisite, double-blind, placebo-controlled, parallel-group randomized clinical trial from the UK examined adults 18 to 65 years of age within 3 years of a first presentation with a functional psychotic disorder who had no contraindication to vitamin D supplementation. A total of 2136 patients were assessed for eligibility, 835 were approached, 686 declined participation or were excluded, 149 were randomized, and 104 were followed up at 6 months. The study recruited participants from January 19, 2016, to June 14, 2019, with the final follow-up (after the last dose) completed on December 20, 2019. INTERVENTIONS Monthly augmentation with 120 000 IU of cholecalciferol or placebo. MAIN OUTCOMES AND MEASURES The primary outcome measure was total Positive and Negative Syndrome Scale (PANSS) score at 6 months. Secondary outcomes included total PANSS score at 3 months; PANSS positive, negative, and general psychopathology subscale scores at 3 and 6 months; Global Assessment of Function scores (for symptoms and disability); Calgary Depression Scale score, waist circumference, body mass index, and glycated hemoglobin, total cholesterol, C-reactive protein, and vitamin D concentrations at 6 months; and a planned sensitivity analysis in those with insufficient vitamin D levels at baseline. RESULTS A total of 149 participants (mean [SD] age, 28.1 (8.5) years; 89 [59.7%] male; 65 [43.6%] Black or of other minoritized racial and ethnic group; 84 [56.4%] White [British, Irish, or of other White ethnicity]) were randomized. No differences were observed in the intention-to-treat analysis in the primary outcome, total PANSS score at 6 months (mean difference, 3.57; 95% CI, -1.11 to 8.25; P = .13), or the secondary outcomes at 3 and 6 months (PANSS positive subscore: mean difference, -0.98; 95% CI, -2.23 to 0.27 at 3 months; mean difference, 0.68; 95% CI, -0.69 to 1.99 at 6 months; PANSS negative subscore: mean difference, 0.68; 95% CI, -1.39 to 2.76 at 3 months; mean difference, 1.56; 95% CI, -0.31 to 3.44 at 6 months; and general psychopathology subscore: mean difference, -2.09; 95% CI, -4.36 to 0.18 at 3 months; mean difference, 1.31; 95% CI, -1.42 to 4.05 at 6 months). There also were no significant differences in the Global Assessment of Function symptom score (mean difference, 0.02; 95% CI, -4.60 to 4.94); Global Assessment of Function disability score (mean difference, -0.01; 95% CI, -5.25 to 5.23), or Calgary Depression Scale score (mean difference, -0.39; 95% CI, -2.05 to 1.26) at 6 months. Vitamin D levels were very low in the study group, especially in Black participants and those who identified as another minoritized racial and ethnic group, 57 of 61 (93.4%) of whom had insufficient vitamin D. The treatment was safe and led to a significant increase in 25-hydroxyvitamin D concentrations. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, no association was found between vitamin D supplementation and mental health or metabolic outcomes at 6 months. Because so few patients with FEP were vitamin D replete, the results of this study suggest that this group would benefit from active consideration in future population health strategies. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN12424842.
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Vitamin A and D Absorption in Adults with Metabolic Syndrome versus Healthy Controls: A Pilot Study Utilizing Targeted and Untargeted LC-MS Lipidomics.
Chatelaine, H, Dey, P, Mo, X, Mah, E, Bruno, RS, Kopec, RE
Molecular nutrition & food research. 2021;(2):e2000413
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SCOPE Persons with metabolic syndrome (MetS) absorb less vitamin E than healthy controls. It is hypothesized that absorption of fat-soluble vitamins (FSV) A and D2 would also decrease with MetS status and that trends would be reflected in lipidomic responses between groups. METHODS AND RESULTS Following soymilk consumption (501 IU vitamin A, 119 IU vitamin D2 ), the triglyceride-rich lipoprotein fractions (TRL) from MetS and healthy subjects (n = 10 age- and gender-matched subjects/group) are assessed using LC-MS/MS. Absorption is calculated using area under the time-concentration curves (AUC) from samples collected at 0, 3, and 6 h post-ingestion. MetS subjects have ≈6.4-fold higher median vitamin A AUC (retinyl palmitate) versus healthy controls (P = 0.07). Vitamin D2 AUC is unaffected by MetS status (P = 0.48). Untargeted LC-MS lipidomics reveals six phospholipids and one cholesterol ester with concentrations correlating (r = 0.53-0.68; P < 0.001) with vitamin A concentration. CONCLUSIONS The vitamin A-phospholipid association suggests increased hydrolysis by PLB, PLRP2, and/or PLA2 IB may be involved in the trend in higher vitamin A bioavailability in MetS subjects. Previously observed differences in circulating levels of these vitamins are likely not due to absorption. Alternate strategies should be investigated to improve FSV status in MetS.
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Evaluation of the Effect Derived from Silybin with Vitamin D and Vitamin E Administration on Clinical, Metabolic, Endothelial Dysfunction, Oxidative Stress Parameters, and Serological Worsening Markers in Nonalcoholic Fatty Liver Disease Patients.
Federico, A, Dallio, M, Masarone, M, Gravina, AG, Di Sarno, R, Tuccillo, C, Cossiga, V, Lama, S, Stiuso, P, Morisco, F, et al
Oxidative medicine and cellular longevity. 2019;:8742075
Abstract
Nowadays, the nonalcoholic fatty liver disease represents the main chronic liver disease in the Western countries, and the correct medical therapy remains a big question for the scientific community. The aim of our study was to evaluate the effect derived from the administration for six months of silybin with vitamin D and vitamin E (RealSIL 100D®) on metabolic markers, oxidative stress, endothelial dysfunction, and worsening of disease markers in nonalcoholic fatty liver disease patients. We enrolled 90 consecutive patients with histological diagnosis of nonalcoholic fatty liver disease and 60 patients with diagnosis of reflux disease (not in therapy) as healthy controls. The nonalcoholic fatty liver disease patients were randomized into two groups: treated (60 patients) and not treated (30 patients). We performed a nutritional assessment and evaluated clinical parameters, routine home tests, the homeostatic model assessment of insulin resistance, NAFLD fibrosis score and fibrosis-4, transient elastography and controlled attenuation parameter, thiobarbituric acid reactive substances, tumor necrosis factor α, transforming growth factor β, interleukin-18 and interleukin-22, matrix metalloproteinase 2, epidermal growth factor receptor, insulin growth factor-II, cluster of differentiation-44, high mobility group box-1, and Endocan. Compared to the healthy controls, the nonalcoholic fatty liver disease patients had statistically significant differences for almost all parameters evaluated at baseline (p < 0.05). Six months after the baseline, the proportion of nonalcoholic fatty liver disease patients treated that underwent a statistically significant improvement in metabolic markers, oxidative stress, endothelial dysfunction, and worsening of disease was greater than not treated nonalcoholic fatty liver disease patients (p < 0.05). Even more relevant results were obtained for the same parameters by analyzing patients with a concomitant diagnosis of metabolic syndrome (p < 0.001). The benefit that derives from the use of RealSIL 100D could derive from the action on more systems able to advance the pathology above all in that subset of patients suffering from concomitant metabolic syndrome.
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Effects of vitamin D supplementation on circulatory YKL-40 and MCP-1 biomarkers associated with vascular diabetic complications: A randomized, placebo-controlled, double-blind clinical trial.
Omidian, M, Mahmoudi, M, Javanbakht, MH, Eshraghian, MR, Abshirini, M, Daneshzad, E, Hasani, H, Alvandi, E, Djalali, M
Diabetes & metabolic syndrome. 2019;(5):2873-2877
Abstract
AIM: Diabetic patients predispose to vascular diseases such as nephropathy, and retinopathy. Poor adherence to medical treatment and dietary recommendations in uncontrolled diabetes leads to vascular damages. Vitamin D has been extensively studied and found to be protective against diabetes mellitus. YKL-40 and Monocyte chemoattractant protein-1 (MCP-1) are considered to exert crucial role in diabetes and its complications. Therefore, this study was designed to investigate effects of vitamin D supplementation on serum levels of YKL-40 and MCP-1 involved in the development of diabetic complications. METHODS For 12 weeks, 48 type 2 diabetic patients enrolled in the trial and randomly were divided into two groups (n = 24 per group), receiving one of the following: 100 μg (4000 IU) vitamin D or placebo. Before and after intervention, serumYKL-40, MCP-1, insulin, IL-6, TNF-α, 25- (OH) vitamin D and HbA1c were measured. RESULTS Our results revealed that serum levels of 25 (OH) vitamin D significantly increased in vitamin D group (p < 0.001). Vitamin D supplementation also significantly reduced serum YKL-40 levels (-22.7 vs. -2.4 ng/ml; (p-value = 0.003)). There was a significant decline in MCP-1 concentration in intervention group at the end of the study (-45.7 vs. -0.9 pg/ml; (p = 0.001)). Furthermore, there was a significant decrease in IL-6, fasting insulin and HOMA-IR in intervention group after 3 months supplementation. CONCLUSIONS Daily vitamin D supplementation effectively reduced circulatory YKL-40 and MCP-1 levels in patients with type-2 diabetes and vitamin D deficiency. Vitamin D might contribute in reducing diabetic complications via modulating YKL-40 and MCP-1 signaling pathways.
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Effects of different vitamin D supplementation strategies in reversing metabolic syndrome and its component risk factors in adolescents.
Al-Daghri, NM, Amer, OE, Khattak, MNK, Sabico, S, Ghouse Ahmed Ansari, M, Al-Saleh, Y, Aljohani, N, Alfawaz, H, Alokail, MS
The Journal of steroid biochemistry and molecular biology. 2019;:105378
Abstract
There is little evidence on the efficacy of various vitamin D supplementation strategies in reversing metabolic syndrome (MetS) in adolescents. The present study aims to fill this gap. A total of 535 (243/292) out of 650 apparently healthy Saudi adolescents were randomly selected from the Vitamin D School Project database which has baseline and post-intervention information of more than 1000 Saudi adolescents 12-18 years old attending 34 schools in Riyadh, Saudi Arabia from Nov 2014-May 2015. Allocation of intervention was done in 3 groups using cluster randomization: vitamin D tablet, 1000IU/day (N = 180; 69 boys, 111 girls); vitamin D fortified milk consumption, 200 ml/day, 40IU/100 ml (N = 189; 93 boys, 96 girls) and control (educational awareness) (N = 166; 81 boys, 85 girls). All groups were given educational awareness on how to increase vitamin D levels. All groups were matched for BMI and analysis adjusted for age. Post-intervention and using intent-to-treat approach, within-group analysis revealed a statistically significant increase in 25(OH)D levels in all groups, and a clinically significant increase in favor of the tablet group (between-group) [10.7 nmol/l (34.7%) versus 6.3 nmol/l (19.8%) in milk and 2.1 nmol/l (7.0%) in control; p < 0.001], adjusted for age and BMI-matched. Between group analysis also revealed a clinically significant decrease in triglycerides (p = 0.05), glucose (p < 0.001) and systolic blood pressure (p = 0.005) as well as a clinically significant increase in HDL-cholesterol (p = 0.004) over time, all in favor of the tablet group. Within-group comparison showed a significant decrease in the incidence of MetS in the tablet group (9.4% versus 4.4%; p < 0.05) only. In conclusion, oral vitamin D supplementation is superior to vitamin D fortified milk in improving vitamin D status. Reduction in the incidence of MetS in the Arab adolescent population secondary to vitamin D correction may be dose-dependent.
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Effects of vitamin D supplementation along with endurance physical activity on lipid profile in metabolic syndrome patients: A randomized controlled trial.
Farag, HAM, Hosseinzadeh-Attar, MJ, Muhammad, BA, Esmaillzadeh, A, Hamid El Bilbeisi, A
Diabetes & metabolic syndrome. 2019;(2):1093-1098
Abstract
BACKGROUND AND OBJECTIVES This study was conducted to determine the effects of vitamin D supplementation along with endurance physical activity on lipid profile among metabolic syndrome patients. MATERIALS AND METHODS In a parallel randomized placebo controlled trial, 70 metabolic syndrome patients, were randomly assigned into three groups. Biochemical tests were assessed as baseline and after 12 weeks of intervention. Statistical analysis was performed using SPSS version 20. RESULTS The mean vitamin D levels was increased significantly in both vitamin D and vitamin D plus physical activity groups (P value < 0.05). No significant change was observed in the placebo group. Additionally, there was a significant decrease in total cholesterol and LDL-C in vitamin D plus physical activity group (P value < 0.05). No significant differences in changes of triglycerides and HDL-C among the three groups (P value > 0.05). While, in vitamin D group a decreased in total cholesterol, HDL-C, LDL-C and increase in triglycerides were observed, but did not reach a statistically significant. CONCLUSION Daily supplementation of vitamin D for 12 weeks, along with moderate endurance physical activity, significantly increase vitamin D concentration and induce a significant reduction in lipid profile in metabolic syndrome patients.
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Effects of vitamin D supplementation on depressive symptoms in type 2 diabetes mellitus patients: Randomized placebo-controlled double-blind clinical trial.
Omidian, M, Mahmoudi, M, Abshirini, M, Eshraghian, MR, Javanbakht, MH, Zarei, M, Hasani, H, Djalali, M
Diabetes & metabolic syndrome. 2019;(4):2375-2380
Abstract
AIM: Diabetes increases the odds of depression and depression is often associated with poor glycemic control and complications of diabetes. Vitamin D is also believed to improve glycemic control and ameliorate depressive symptoms. Therefore, we examined effects of vitamin D monotherapy (without antidepressant drugs) on depressive symptoms in Type 2 diabetic patients with mild to moderate depressive symptoms. METHODS We conducted 12 weeks, placebo-controlled, double-blind, randomized trial on 68 subjects with T2DM and mild to moderate depressive symptoms. Subjects received 100 μg (4000 IU) vitamin D (n = 32) or placebo (n = 34) daily. Beck Depression Inventory-II (BDI-II-PERSIAN) was applied for assessment of the severity of depression. Depression scores and metabolic profiles were measured at the beginning and end of trail. RESULTS after 3 months of vitamin D supplementation, mean values of 25(OH) D increased from 15.5 ± 8.8 to 32.2 ± 8.9 ng/ml (p-value <0.001) in the vitamin D group. Moreover, BDI-II scores decreased from 15.2 ± 9.6 to 9.8 ± 7.2 (p-value <0.001) in the vitamin D group and 15.5 ± 11.2 to 13.7 ± 11.5 (p-value = 0.03) in placebo group. This decrease in BDI-II scores were significant (27.6% vs 10.8%) compared with placebo (p-value = 0.02). In term of metabolic profiles, mean change in level of Hemoglobin A1c (HbA1c), insulin and triglycerides (TG) were significantly higher in response to the treatment with vitamin D compared to placebo (p-value <0.02). CONCLUSIONS In conclusion, supplementation of vitamin D in T2DM patients may protect these patients against the onset of major depressive disorder (MDD), with noticeable favorable effects on measures of metabolic profiles. TRIAL REGISTRATION NCT03008057.