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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
121
60,000 IU per week for 8 weeks
placebo +diet and lifestyle
Fortis CDOC center of Excellence for Diabetes Obesity and Endocrinoogy, New Delhi, India
Delhi, India
fasting glucose (mg/dL)
Time frame: 2 years
TC (mg/dL)
Time frame: 2 years
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