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Completed

NCT Number: NCT02513888

Prevention of Type 2 Diabetes With Vitamin D Supplementation

PREVENT-WIN study has three components.

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.

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, leaflets/booklets 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.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Rural Health Services Project, AIIMS

Ballabgarh, Haryana, 121004, India

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Prediabetes:
  • Fasting blood glucose ≥100mg/dl and <126mg/dl, or
  • 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 g anhydrous oral glucose), and 2. Baseline level of 25 hydroxy vitamin D <30ng/dl. 3. Women aged 20-60 years

Exclusion criteria

  • Received Vitamin D and/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 (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.)
  • Pregnancy and lactation at the time of study.
  • Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
  • Known case of HIV infection.
  • Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas
  • Known case of diabetes mellitus. -

Treatment and study plan

vitamin D + diet and lifestyle

Dietary Supplement

subjects will be given vitamin D along with diet and lifestyle modification counselling

Placebo + diet and lifestyle

Dietary Supplement

placebo along with diet and lifestyle modification counselling

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
2017
First posted
Aug 3, 2015
Registry last updated
Jun 27, 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.

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