Skip to main content
OpenTrials
Completed

NCT Number: NCT02513875

Prevention of Type 2 Diabetes With Vitamin D

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Delhi, 110048, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

60,000 IU per week for 8 weeks

Placebo

Dietary Supplement

placebo +diet and lifestyle

Primary outcomes

  1. fasting glucose (mg/dL)

    Time frame: 2 years

Secondary outcomes

  1. TC (mg/dL)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Collaborators

  • Ministry of Science and Technology, India

Registry information

Official study title

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

Acronym: PREVENT-WIN

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Aug 3, 2015
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.