Prevention of Type 2 Diabetes With Vitamin D Supplementation

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

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 + diet and lifestyle
* Dietary Supplement: Placebo + diet and lifestyle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Prediabetes: Fasting blood glucose ≥100mg/dl and <126mg/dl, or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 g anhydrous oral glucose), and 2. Baseline level of 25 hydroxy vitamin D <30ng/dl. 3. Women aged 20-60 years Exclusion Criteria: Received Vitamin D and/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 (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.) Pregnancy and lactation at the time of study. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc. Known case of HIV infection. Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas Known case of diabetes mellitus. -

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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D + diet and lifestyle<br>subjects will be given vitamin D supplement will be given along with diet nd lifestyle modification | Dietary Supplement: vitamin D + diet and lifestyle<br>* subjects will be given vitamin D along with diet and lifestyle modification counselling<br>|
| Placebo Comparator: placebo + diet and lifestyle<br>Subjects will be given placebo with diet and lifestyle | Dietary Supplement: Placebo + diet and lifestyle<br>* placebo along with diet and lifestyle modification counselling<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 |