120
Participants
Start Date
September 1, 2023
Primary Completion Date
June 30, 2026
Study Completion Date
August 30, 2026
Vitamin D supplementation
Appropriate diet and physical activity counselling to both groups. Supplementation with Vitamin D and oral Calcium-Doses of cholecalciferol (commercial name, Calcirol) 60,000 IU (sachets, dissolved in half glass milk) once per week for eight weeks for the intervention group and placebo (Lactose granules) to the placebo group according to the random numbers generated by the computer. After every 24 weeks blood 25 (OH) D levels will be assessed. If the subjects are found to be still deficient then supplementation of cholecalciferol 60,000 IU per week for eight weeks will be repeated.If the 25 (OH) D levels are normal, then cholecalciferol supplementation in doses of 200 IU per day will be given as a maintenance dose. Equal doses of calcium carbonate (1gm per day, commercial name Calcal) will be given to both the groups.
Diabetes Foundation, India
OTHER