Prevention of Type 2 Diabetes With Vitamin D

Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India (PREVENT-WIN Study)

The work plan will have the following S&T components. Component 1: Cross-sectional Study

Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure.

Component 2: Prospective Study

This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared.

Inclusion Criteria:

• Healthy women aged 20-60 years.

Exclusion Criteria:

• Received Vitamin D or calcium supplementation in the previous six months.
• On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. metformin, thiazolidenediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation
• Pregnancy and lactation at time of study
• Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
• Known case of HIV infection.
• Known case of diabetes mellitus and other endocrine disorders.