Ignite Creation Date:
2024-05-06 @ 7:20 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02513875
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2015-07-29
Brief Title:
Prevention of Type 2 Diabetes With Vitamin D
Sponsor:
Diabetes Foundation India
Organization:
Diabetes Foundation India
Study Overview
Official Title:
Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India PREVENT-WIN Study
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENT-WIN
Brief Summary:
The work plan will have the following ST components Component 1 Cross-sectional Study
Cross-sectional study will be of 15 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
Cross-sectional study will be of 15 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None