NCT02513875

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Diabetes Foundation, India · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D	60,000 IU per week for 8 weeks
DIETARY_SUPPLEMENT	Placebo	placebo +diet and lifestyle

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-12-31
• Completion: 2018-01-25
• First posted: 2015-08-03
• Last updated: 2023-06-15

Locations

1 site across 1 country: India