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1.
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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3.
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.
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The effects of vitamin D supplementation on metabolic profiles and gene expression of insulin and lipid metabolism in infertile polycystic ovary syndrome candidates for in vitro fertilization.
Dastorani, M, Aghadavod, E, Mirhosseini, N, Foroozanfard, F, Zadeh Modarres, S, Amiri Siavashani, M, Asemi, Z
Reproductive biology and endocrinology : RB&E. 2018;(1):94
Abstract
BACKGROUND Vitamin D deficiency in women diagnosed with polycystic ovary syndrome (PCOS) remarkably decreases the chance of pregnancy, which might be related to its impact on metabolic abnormalities in these patients. It is hypothesized that vitamin D supplementation influences metabolic profile of these patients and indirectly might affect fertility and the outcomes. Therefore, this study was conducted to determine the effects of vitamin D supplementation on the levels of anti-Müllerian hormone (AMH), metabolic profiles, and gene expression of insulin and lipid metabolism in infertile women with PCOS who were candidate for in vitro fertilization (IVF). METHODS This study was a randomized, double-blinded, placebo-controlled trial conducted among 40 infertile women, aged 18-40 years, diagnosed with PCOS and was candidate for IVF. Participants were randomly assigned into two intervention groups for receiving either 50,000 IU vitamin D or placebo (n = 20 each group) every other week for 8 weeks. Gene expression for insulin and lipid metabolism was conducted using peripheral blood mononuclear cells (PBMCs) of women with PCOS, via RT-PCR method. RESULTS Vitamin D supplementation led to a significant reduction in serum AMH (- 0.7 ± 1.2 vs. - 0.1 ± 0.5 ng/mL, P = 0.02), insulin levels (- 1.4 ± 1.6 vs. -0.3 ± 0.9 μIU/mL, P = 0.007), homeostatic model of assessment for insulin resistance (- 0.3 ± 0.3 vs. -0.1 ± 0.2, P = 0.008), and a significant increase in quantitative insulin sensitivity check index (+ 0.009 ± 0.01 vs. + 0.001 ± 0.004, P = 0.04), compared with the placebo. Moreover, following vitamin D supplementation there was a significant decrease in serum total- (- 5.1 ± 12.6 vs. + 2.9 ± 10.9 mg/dL, P = 0.03) and LDL-cholesterol levels (- 4.5 ± 10.3 vs. + 2.5 ± 10.6 mg/dL, P = 0.04) compared with the placebo. CONCLUSION Overall, the findings of this trial supported that 50,000 IU vitamin D supplementation every other week for 8 weeks had beneficial effects on insulin metabolism, and lipid profile of infertile women with PCOS who are candidate for IVF. These benefits might not be evident upon having sufficient vitamin D levels. TRIAL REGISTRATION This study was retrospectively registered in the Iranian website ( www.irct.ir ) for clinical trials registration ( http://www.irct.ir : IRCT20170513033941N27).
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Vitamin D supplementation for the treatment of non-alcoholic fatty liver disease: A randomized double blind placebo controlled trial.
Dabbaghmanesh, MH, Danafar, F, Eshraghian, A, Omrani, GR
Diabetes & metabolic syndrome. 2018;(4):513-517
Abstract
BACKGROUND Low serum vitamin D has been associated with metabolic syndrome and Non-alcoholic fatty liver disease (NAFLD). This study aimed to investigate the impact of vitamin D supplementation in treatment of patients with NAFLD. METHODS In a double blind, randomized, placebo controlled trial patients with NAFLD were randomized to receive one weekly pearl of placebo, 50,000 U vitamin D3 (cholecalciferol) pearl per week and 0.25 mg calcitriol (1,25 dihydroxycholecalciferol) pearl per day for 3 months. RESULTS 106 NAFLD patients were randomized to receive calcitriol, vitamin D3 and placebo pearls for 12 weeks and data for 91 patients were analyzed. After 12 weeks of treatment, serum alkaline phosphatase levels was significantly decreased from baseline levels in vitamin D and calcitriol treated groups (P < 0.05). Serum and gamma glutamyl transferase (GGT) level was also significantly decreased compared to the baseline levels after 12 weeks of treatment with vitamin D. There was no statistically significant difference between placebo, calcitriol, vitamin D groups in terms of serum aminotransferase, alkaline phosphatase, serum GGT and lipid profile (P > 0.05). CONCLUSION While significant reduction of serum alkaline phosphatase and GGT were seen with vitamin D and calcitriol supplementation from baseline levels, no beneficial effects was seen when comparing vitamin D, calcitriol and placebo groups at the end of trial.
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Effect of oral vitamin D supplementation on glycemic control in patients with type 2 diabetes mellitus with coexisting hypovitaminosis D: A parellel group placebo controlled randomized controlled pilot study.
Upreti, V, Maitri, V, Dhull, P, Handa, A, Prakash, MS, Behl, A
Diabetes & metabolic syndrome. 2018;(4):509-512
Abstract
CONTEXT Vitamin D supplementation in type 2 diabetes mellitus patients may lead to improved glycemic control by improving insulin secretion and decreasing insulin resistance. AIMS To investigate effect of oral vitamin D supplementation on glycemic control, in patients with type 2 diabetes mellitus and coexisting hypovitaminosis D. SETTINGS AND DESIGN Randomized, Parallel Group, Placebo Controlled Trial carried out in a tertiary care hospital of Indian Armed Forces. METHODS AND MATERIAL Sixty patients with coexisting type 2 diabetes mellitus and hypovitaminosis D were randomized into cases and controls and were supplemented with oral Vitamin D and microcrystalline cellulose respectively for six months. Subjects' HbA1c and vitamin D levels were monitored at the beginning and end of the study, fasting plasma glucose (FPG) & post prandial plasma glucose (PPPG) during monthly OPD visits. STATISTICAL ANALYSIS USED Intra-group comparison was made by paired t test & unpaired t test was used for inter-group (A v/s B) comparisons. Repeated measures ANOVA was undertaken to compare values over time. RESULTS The two groups were comparable for all parameters at baseline. Case group showed significant decrease in mean HbA1c levels (7.29% to 7.02%; P = 0.01), mean FPG levels (131.4 to 102.6 mg/dl; P = 0.04) and mean PPPG levels (196.2 to 135.0 mg/dl; P < 0.001). Incidentally, significant improvement in systolic as well as diastolic blood pressure and total cholesterol was also noted in the cases, while for LDL cholesterol improvement tended towards significance (p = 0.05). CONCLUSIONS We found that oral vitamin D supplementation was associated with improved glycemic control and other metabolic parameters in patients with type 2 diabetes mellitus. Supplementation to achieve normal levels of vitamin D can be a promising adjuvant therapy for T2DM patients & coexisting hypovitaminosis D.
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Effect of vitamin D supplementation on anthropometric indices among overweight and obese women: A double blind randomized controlled clinical trial.
Roosta, S, Kharadmand, M, Teymoori, F, Birjandi, M, Adine, A, Falahi, E
Diabetes & metabolic syndrome. 2018;(4):537-541
Abstract
AIMS: The aim of this study was to investigate effect of vitamin D supplementation on anthropometric indices among women with overweight and obesity. METHODS This double blind randomize clinical trial was conducted on 66 overweight and obese women. Those in intervention group received oral supplement of vitamin D 50,000 IU (1250 mcg) per 25 day and in control group participants received placebo for 3 months. Anthropometric indices were measured before and after 3 months intervention. Before the intervention a 24-h dietary recall (3 days) were used to assess dietary intake of individuals. Independent t test and multivariate repeated measure were used to data analysis. RESULTS The mean difference of anthropometric indices, serum calcium, 25 (OH) D3 and serum PTH between the intervention and control groups were significant (P < 0/05). However, no significant differences in serum phosphorus between the intervention and control groups were seen. CONCLUSION Supplementation with vitamin D 50 μg for each day for 3 months resulted in a significant reduction in anthropometric indices in women with obesity and overweight with normal primary 25(OH) D3 serum levels.