NCT01375660

D Vitamin Intervention in VA

Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: Male
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will supplement African American male (AAM) veterans at risk for diabetes and newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps to improve early markers of diabetes. The study will be done at Veteran Administration Medical Center in Chicago.

Detailed description

The goal of this randomized clinical trial (RCT) is to determine vitamin D efficacy and safety for improving early markers of T2DM in African American male (AAM) veterans at risk for T2DM (n=205, duration 12 months). The primary outcome will be change in oral glucose insulin sensitivity (OGIS). The secondary outcomes will include various parameters of glucose metabolism and other biomarkers. Analysis based on primary and secondary goal as well as predetermined levels of A1C, OGTT and 25OHD at the end of the study.

Conditions

• Impaired Fasting Glucose
• Impaired Glucose Tolerance
• Vitamin D Insufficiency

Interventions

Type	Name	Description
DRUG	Placebo	Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K
DRUG	50K vitamin D2	Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-10-01
• Completion: 2014-11-01
• First posted: 2011-06-17
• Last updated: 2015-03-06
• Results posted: 2015-02-05

Locations

1 site across 1 country: United States