Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02513888
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2015-07-29
Brief Title:
Prevention of Type 2 Diabetes With Vitamin D Supplementation
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:
2018-07
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:
PREVENT-WIN study has three components
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
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 leafletsbooklets 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
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
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 leafletsbooklets 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
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