Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320853
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2006-05-01
Brief Title:
A Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion
Sponsor:
Sitaram Bhartia Institute of Science and Research
Organization:
Sitaram Bhartia Institute of Science and Research
Study Overview
Official Title:
A Pilot Study to Evaluate the Effect of Vitamin D Supplementation on Insulin Secretion and Peripheral Insulin Sensitivity
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 syndromeThe 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 settingshealthy volunteers and postmenopausal womenWe therefore planned this trial to study the effect of vitamin D supplementation 240000 IU on insulin secretion and peripheral insulin sensitivityThis 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 comparisonSingle 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 design and comparisonSingle 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None