Prevention of Type 2 Diabetes With Vitamin D Supplementation

NCT ID: NCT02513888

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2017-12-31

Brief Summary

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.

Conditions

Prediabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D + diet and lifestyle

subjects will be given vitamin D supplement will be given along with diet nd lifestyle modification

Group Type: EXPERIMENTAL

vitamin D + diet and lifestyle

Intervention Type: DIETARY_SUPPLEMENT

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

placebo + diet and lifestyle

Subjects will be given placebo with diet and lifestyle

Group Type: PLACEBO_COMPARATOR

Placebo + diet and lifestyle

Intervention Type: DIETARY_SUPPLEMENT

placebo along with diet and lifestyle modification counselling

Interventions

vitamin D + diet and lifestyle

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo + diet and lifestyle

placebo along with diet and lifestyle modification counselling

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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. -

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, India

OTHER_GOV

Sponsor Role: collaborator

Diabetes Foundation, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Anoop Misra

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Puneet Misra, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences, New Delhi, India

Locations

Comprehensive Rural Health Services Project, AIIMS

Ballabgarh, Haryana, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 34660457 (View on PubMed)

Other Identifiers

PREVENT_WIN_RURAL

Identifier Type: -

Identifier Source: org_study_id