A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity|
- OGIS Index, Total Insulin Secretion
- ISI composite
- ISI stumvoll
- ISI Gutt
- Insulinogenic Index
- Lipid profile
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||May 2006|
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.
|Sitaram Bhartia Institute of Science and Research|
|New Delhi, Delhi, India, 110016|
|Principal Investigator:||Jitendra N Pande, MD||Sitaram Bhartia Institute of Science and Research|
|Principal Investigator:||Jitender Nagpal, MD||Sitaram Bhartia Institute of Science and Research|
|Study Director:||Abhishek Bhartia, ME||Sitaram Bhartia Institute of Science and Research|
|Study Chair:||Anupama Singh, MD||Sitaram Bhartia Institute of Science and Research|