Prevention of Type 2 Diabetes With Vitamin D

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Dietary Supplement: vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT02513875
• Lead Sponsor: Diabetes Foundation, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study Start: 2013-02
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-08-03
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-25
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D with diet and lifestyle	vitamin D	vitamin D supplementation along with diet and lifestyle modification was given
placebo with diet and lifestyle modification	Placebo	placebo with diet and lifestyle modification was given

Primary Outcome Measures

Name	Time	Method
fasting glucose (mg/dL)	2 years

Secondary Outcome Measures

Name	Time	Method
TC (mg/dL)	2 years

Trial Locations

Locations (1)

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