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| Name | Class |
|---|---|
| Ministry of Science and Technology, India | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D with diet and lifestyle | Experimental | vitamin D supplementation along with diet and lifestyle modification was given |
|
| placebo with diet and lifestyle modification | Placebo Comparator | placebo with diet and lifestyle modification was given |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Dietary Supplement | 60,000 IU per week for 8 weeks |
| |
| 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anoop Misra, MD | Diabetes Foundation, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis CDOC center of Excellence for Diabetes Obesity and Endocrinoogy, New Delhi, India | Delhi | 110048 | India |
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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 |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Dietary Supplement |
placebo +diet and lifestyle |
|
| D004700 | Endocrine System Diseases |