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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02513875
Study type Interventional
Source Diabetes Foundation, India
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date January 25, 2018

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