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| Name | Class |
|---|---|
| Ministry of Science and Technology, India | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D + diet and lifestyle | Experimental | subjects will be given vitamin D supplement will be given along with diet nd lifestyle modification |
|
| placebo + diet and lifestyle | Placebo Comparator | Subjects will be given placebo with diet and lifestyle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D + diet and lifestyle | Dietary Supplement | subjects will be given vitamin D along with diet and lifestyle modification counselling |
|
| Measure | Description | Time Frame |
|---|---|---|
| fasting glucose (mg/dL) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| TC (mg/dL) | 2 years |
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Inclusion Criteria:
1. Prediabetes:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Puneet Misra, MD | All India Institute of Medical Sciences, New Delhi, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Rural Health Services Project, AIIMS | Ballabgarh | Haryana | 121004 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34660457 | Derived | Misra P, Kant S, Misra A, Jha S, Kardam P, Thakur N, Bhatt SP. 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. J Family Med Prim Care. 2021 Aug;10(8):3122-3129. doi: 10.4103/jfmpc.jfmpc_311_21. Epub 2021 Aug 27. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D004032 | Diet |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo + diet and lifestyle | Dietary Supplement | placebo along with diet and lifestyle modification counselling |
|
| D004700 | Endocrine System Diseases |
| D009747 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |