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

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: vitamin D + diet and lifestyle; Dietary supplement: Placebo + diet and lifestyle

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Puneet Misra, MD; Phone Number: 41759672; Email: doctormisra@gmail.com

Study Locations

• India
  • Haryana
    • Ballabgarh, Haryana, India, 121004
      • Comprehensive Rural Health Services Project, AIIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Prediabetes:

  1. Fasting blood glucose ≥100mg/dl and <126mg/dl, or
  2. 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:

1. Received Vitamin D and/or calcium supplementation in the previous six months.
2. 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.)
3. Pregnancy and lactation at the time of study.
4. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
5. Known case of HIV infection.
6. Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas
7. Known case of diabetes mellitus. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D + diet and lifestyle; subjects will be given vitamin D supplement will be given along with diet nd lifestyle modification	Dietary supplement: vitamin D + diet and lifestyle; subjects will be given vitamin D along with diet and lifestyle modification counselling
Placebo Comparator: placebo + diet and lifestyle; Subjects will be given placebo with diet and lifestyle	Dietary supplement: Placebo + diet and lifestyle; placebo along with diet and lifestyle modification counselling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India
• Collaborators: Ministry of Science and Technology, India
• Investigators: Principal Investigator: Puneet Misra, MD, All India Institute of Medical Sciences, New Delhi, India

Publications and helpful links

General Publications

• Misra P, Kant S, Misra A, Jha S, Kardam P, Thakur N, Bhatt SP. A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India. J Family Med Prim Care. 2021 Aug;10(8):3122-3129. doi: 10.4103/jfmpc.jfmpc_311_21. Epub 2021 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

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 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: PREVENT_WIN_RURAL