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

Sitaram Bhartia Institute of Science and Research

Status

Completed

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Treatments

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT00320853

SBISR/2006/02

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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