An interventional study of Vitamin D in Diabetes Mellitus, Non-Insulin-Dependent, sponsored by Sitaram Bhartia Institute of Science and Research. Completed at 1 site in India. Open to male participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-05-03.
Sponsored by Sitaram Bhartia Institute of Science and Research · Not applicable, Interventional, and Prevention
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.
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Sitaram Bhartia Institute of Science and Research is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OGIS Index, Total Insulin Secretion
HOMA
QUICKI
ISI composite
ISI stumvoll
ISI Gutt
Insulinogenic Index
Lipid profile
CRP
ApoA1
ApoB
This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.
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Sitaram Bhartia Institute of Science and Research