NCT02513888

Prevention of Type 2 Diabetes With Vitamin D Supplementation

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

PREVENT-WIN study has three components. 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. Component 3: Information Education and Communication (IEC) Activities: There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas. IEC material will be developed and IEC activities through various modes like lectures, workshops, group discussions, leaflets/booklets distribution and audio video media shows (Hindi and English) will be used for educating health professionals, Medical and paramedical workers and various village level health functionaries like, Multi purpose workers, anganwadi workers, Accredited Social Health Activist under National Rural Health Mission of Government of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and adverse health effects of vitamin D deficiency.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D + diet and lifestyle	subjects will be given vitamin D along with diet and lifestyle modification counselling
DIETARY_SUPPLEMENT	Placebo + diet and lifestyle	placebo along with diet and lifestyle modification counselling

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2015-08-03
• Last updated: 2023-06-27

Locations

1 site across 1 country: India