NCT02513888: PREVENT-WIN

Prevention of Type 2 Diabetes With Vitamin D Supplementation

Completed NA Last updated 27 June 2023

What this trial tests

NA trial testing vitamin D + diet and lifestyle in Prediabetes in 121 participants. Completed in 31 December 2017.

Timeline

1 February 2013

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	Diabetes Foundation, India
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	health services research
Enrollment	121
Start date	1 February 2013
Primary completion	31 December 2017
Estimated completion	31 December 2017
Sites	1 location across India

Drugs / interventions tested

• vitamin D + diet and lifestyle
• Placebo + diet and lifestyle

Conditions studied

• Prediabetes — all drugs for Prediabetes →

Sponsor

Diabetes Foundation, India

Who can join

Adults 20 to 60, female only, with Prediabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India.
   Misra P, Kant S, Misra A, Jha S, et al · · 2021 · cited 8× · PMID 34660457 · DOI 10.4103/jfmpc.jfmpc_311_21