Prevention of Type 2 Diabetes With Vitamin D

NCT02513875 | Completed DMC

• 1 other identifier: PREVENT-WIN 2012
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• fasting glucose (mg/dL)

  2 years

Secondary Outcomes (1)

• TC (mg/dL)

  2 years

Study Arms (2)

vitamin D with diet and lifestyle

EXPERIMENTAL

vitamin D supplementation along with diet and lifestyle modification was given

Dietary Supplement: vitamin D

placebo with diet and lifestyle modification

PLACEBO COMPARATOR

placebo with diet and lifestyle modification was given

Dietary Supplement: Placebo

Interventions

vitamin D DIETARY_SUPPLEMENT

60,000 IU per week for 8 weeks

vitamin D with diet and lifestyle

Placebo DIETARY_SUPPLEMENT

placebo +diet and lifestyle

placebo with diet and lifestyle modification

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 20-60 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

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

Delhi, 110048, India

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anoop Misra, MD

  Diabetes Foundation, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 3, 2015
• Study Start: February 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: January 25, 2018
• Last Updated: June 15, 2023

Record last verified: 2012-07

Locations

IN (1)