Prevention of Type 2 Diabetes With Vitamin D

Prediabetes Clinical Trial

— PREVENT-WIN  

Official title:

Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India (PREVENT-WIN Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513875
• Other study ID #: PREVENT-WIN 2012
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

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