Status:
COMPLETED
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
American Diabetes Association
Conditions:
Vitamin D Deficiency
Insulin Resistance
Eligibility:
All Genders
25-80 years
Phase:
NA
Brief Summary
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. ...
Detailed Description
This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- 25 (OH) vitamin D levels \< 25 ng/ml
- Age 25 to 80 years
- Not on insulin for diabetes treatment
- HbA1c 5.5% -9.5%
- Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications
Exclusion
- Pregnancy
- Patients with systolic \>160 or diastolic \>100 mmHg
- High urine calcium or history of recurrent kidney stones
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2019
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00736632
Start Date
May 1 2006
End Date
January 13 2019
Last Update
February 10 2020
Active Locations (1)
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1
Washington Universiy
St Louis, Missouri, United States, 63110