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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02513875

Acronym

PREVENT-WIN

Enrollment

121

Registered

2015-08-03

Start date

2013-02-28

Completion date

2018-01-25

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Brief 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.

Interventions

DIETARY_SUPPLEMENTvitamin D

60,000 IU per week for 8 weeks

DIETARY_SUPPLEMENTPlacebo

placebo +diet and lifestyle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women aged 20-60 years.

Exclusion criteria

* Received Vitamin D or calcium supplementation in the previous six months. * On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. metformin, thiazolidenediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation * Pregnancy and lactation at time of study * Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc. * Known case of HIV infection. * Known case of diabetes mellitus and other endocrine disorders.

Design outcomes

Primary

Measure	Time frame
fasting glucose (mg/dL)	2 years

Secondary

Measure	Time frame
TC (mg/dL)	2 years

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026