Prevention of Type 2 Diabetes With Vitamin D (PREVENT-WIN)

Diabetes Foundation, India

Status: Completed

Conditions: Prediabetes

Treatments: Dietary Supplement: vitamin D; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02513875

PREVENT-WIN 2012

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups, including a placebo group

vitamin D with diet and lifestyle

Experimental group

Description:

vitamin D supplementation along with diet and lifestyle modification was given

Treatment:

Dietary Supplement: vitamin D

placebo with diet and lifestyle modification

Placebo Comparator group

Description:

placebo with diet and lifestyle modification was given

Treatment:

Dietary Supplement: Placebo