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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02513875
Other study ID # PREVENT-WIN 2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2013
Est. completion date January 25, 2018

Study information

Verified date July 2012
Source Diabetes Foundation, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date January 25, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
vitamin D
60,000 IU per week for 8 weeks
Placebo
placebo +diet and lifestyle

Locations

Country Name City State
India Fortis CDOC center of Excellence for Diabetes Obesity and Endocrinoogy, New Delhi, India Delhi

Sponsors (2)

Lead Sponsor Collaborator
Diabetes Foundation, India Ministry of Science and Technology, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary fasting glucose (mg/dL) 2 years
Secondary TC (mg/dL) 2 years
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