A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent

• Registration Number: NCT00320853
• Lead Sponsor: Sitaram Bhartia Institute of Science and Research

Brief Summary

The purpose of the study is to evaluate the change in insulin sensitivity and secretion indices (early markers for development of diabetes) after 4 weeks of a megadose of Vitamin D. This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

Detailed Description

Accumulating evidence suggests that serum Vitamin D levels may be inversely related to the prevalence of diabetes, to the concentration of glucose , insulin resistance and metabolic syndrome.The available trials have been conducted using small sample sizes in different subgroups (hemodialyzed patients , healthy volunteers , gestational diabetes and post menopausal women ) document variable results with a positive result in some (hemodialysis and gestational diabetes) and no effect in other settings(healthy volunteers and postmenopausal women).We therefore, planned this trial to study the effect of vitamin D supplementation (240,000 IU) on insulin secretion and peripheral insulin sensitivity.This will also help to calculate sample size for and choose an appropriate index for a larger randomized control trial which may be required subsequently.

Study design and comparison:Single group, open label intervention trial involving assessment of insulin sensitivity and secretion in 30 volunteers before and after 4weeks of a megadose of Vitamin D. The pre and post intervention results will be compared using the paired t test.

Study Timeline

• Study Start: 2006-04
• Status Verified: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Last Update Submitted: 2006-05-01
• Study First Posted: 2006-05-03
• Last Update Posted: 2006-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Male
• ≥30 years of age
• Waist circumference ≥80 cm

Exclusion Criteria

• Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
• BP>140/90 or on anti-hypertensive medication
• Receiving Vitamin D or calcium supplementation
• Chronic disease-renal/hepatic/malignancy/gastrointestinal
• On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
• Febrile illness or infective morbidity in the past 10 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
OGIS Index, Total Insulin Secretion

Secondary Outcome Measures

Name	Time	Method
ApoA1
ApoB
HOMA
QUICKI
ISI composite
ISI stumvoll
ISI Gutt
Insulinogenic Index
Lipid profile
CRP

Trial Locations

Locations (1)

Sitaram Bhartia Institute of Science and Research; 🇮🇳 New Delhi, Delhi, India