Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
121 participants
INTERVENTIONAL
2013-02-28
2018-01-25
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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vitamin D with diet and lifestyle
vitamin D supplementation along with diet and lifestyle modification was given
vitamin D
60,000 IU per week for 8 weeks
placebo with diet and lifestyle modification
placebo with diet and lifestyle modification was given
Placebo
placebo +diet and lifestyle
Interventions
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vitamin D
60,000 IU per week for 8 weeks
Placebo
placebo +diet and lifestyle
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
60 Years
FEMALE
Yes
Sponsors
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Ministry of Science and Technology, India
OTHER_GOV
Diabetes Foundation, India
OTHER
Responsible Party
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Dr Anoop Misra
Principal Investigator
Principal Investigators
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Anoop Misra, MD
Role: PRINCIPAL_INVESTIGATOR
Diabetes Foundation, India
Locations
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Fortis CDOC center of Excellence for Diabetes Obesity and Endocrinoogy, New Delhi, India
Delhi, , India
Countries
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Other Identifiers
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PREVENT-WIN 2012
Identifier Type: -
Identifier Source: org_study_id
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