Prevention of Type 2 Diabetes With Vitamin D (PREVENT-WIN)

June 13, 2023 updated by: Dr Anoop Misra, Diabetes Foundation, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India, 110048
        • Fortis CDOC center of Excellence for Diabetes Obesity and Endocrinoogy, New Delhi, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D with diet and lifestyle
vitamin D supplementation along with diet and lifestyle modification was given
Dietary supplement: vitamin D
60,000 IU per week for 8 weeks
Placebo Comparator: placebo with diet and lifestyle modification
placebo with diet and lifestyle modification was given
Dietary supplement: Placebo
placebo +diet and lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fasting glucose (mg/dL)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
TC (mg/dL)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Collaborators

Ministry of Science and Technology, India

Investigators

  • Principal Investigator: Anoop Misra, MD, Diabetes Foundation, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 25, 2018

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimated)

August 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT-WIN 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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