Inventi Rapid: Clinical Research

Inventi:prcr/43813/21

Vitamin D Supplementation in Subjects with T2DM: A Randomised Control Trial to Study the Impact at Two Time Intervals

Vitamin-D deficiency is linked with pathogenesis of type-2 Diabetes Mellitus (T2DM), hypertension and cardiovascular diseases. Evidence shows vitamin-D supplementation may improve biochemical parameters in T2DM subjects. However data on the optimum dose schedule of vitamin-D and its sustainable serum levels in T2DM is not known. The aim was to study impact of cholecalciferol (vitamin-D3) granules on anthropometric, blood-pressure measurements and biochemical parameters in T2DM subjects. Secondly to determine the washout effect of supplementation on the serum vitamin-D levels and cardio-metabolic profile of the subjects at sixteen weeks. Ninety-four T2DM subjects (age 30-65 years, serum vitamin-D levels <20ng/mL) were selected following a prior cross sectional study on 114 T2DM participants for the determination of vitamin D status, who were then randomly divided in two groups; supplementation group (SG) receiving weekly 60,000 International Units (IU) cholecalciferol granules for 8 weeks and the control group (CG) receiving no supplementation. However only 70 subjects (SG=40 and CG=30) completed the trial. Anthropometric and blood pressure measurements were recorded and fasting blood samples were taken for estimation of biochemical parameters like 25(OH)D, lipid profile, HbA1c before and after 8-weeks and at 16-weeks (n=48; SG=35, CG=13) of supplementation. Independent t-test was done for between the groups comparison, while for within the groups paired t-test was applied. F-value was computed using one-way ANOVA for within the group differences for washout effect. After 8-weeks of supplementation significant rise (p<0.001) for serum vitamin-D was seen in SG, with about 83% subjects achieving levels >30ng/mL. However after 16-weeks only 14% could sustain these levels. Weight, waist-circumference, total cholesterol and LDL-C significantly decreased in SG, post intervention. Significant drop (F-test p<0.05) was seen in waist-circumference of SG at 16-weeks as compared to CG. LDL-C increased significantly (p<0.001 for SG and p<0.01 for CG) after 16 weeks. No significant changes were observed for rest of the anthropometric measurements and biochemical parameters. Vitamin-D supplementation (60,000 IU) favourably improved the anthropometric and lipid parameters among the subjects. However serum vitamin-D levels dropped significantly over a period of eight weeks post supplementation which calls for future research to study the required dosage for supplementation and recommendation for maintenance dose to sustain sufficient vitamin-D levels....