Prevention of Type 2 Diabetes With Vitamin D

Study Overview
=================
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.

Official Title
-----------------
Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India (PREVENT-WIN Study)

Conditions
-----------------
Prediabetes

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D with diet and lifestyle<br>vitamin D supplementation along with diet and lifestyle modification was given | Dietary Supplement: vitamin D<br>* 60,000 IU per week for 8 weeks<br>|
| Placebo Comparator: placebo with diet and lifestyle modification<br>placebo with diet and lifestyle modification was given | Dietary Supplement: Placebo<br>* placebo +diet and lifestyle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glucose (mg/dL) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TC (mg/dL) |  | 2 years |