Status:
COMPLETED
Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes
Lead Sponsor:
University of Florida
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
Brief Summary
This pilot study will investigate the effect of Vitamin D supplementation in improving glucose control with patients with poorly controlled diabetes and concurrent Vitamin D deficiency.
Detailed Description
Subject will undergo screening procedures, subject will have blood drawn from a vein in your arm to measure subject's Vitamin D level (about 1 tablespoon).If the subject is eligible based on the resul...
Eligibility Criteria
Inclusion
- diagnosis of type 2 diabetes (per ADA criteria), on antihyperglycemic medications for at least 6 months and
- HbAlc value of 7.5%-10% 7-12%for at least 3 months prior to screening, and
- deficiency level of serum 25 (OH) Vitamin D i.e. below20 25 ng/mL at time of screening, but normal serum calcium values of 8.5-10.5mg/dL and
- on either angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blockade (ARB) antihypertensive medication
Exclusion
- Any subjects with history of end-stage renal disease or frank proteinuria on urinalysis
- Any subjects with pregnancy at time of screening
- Any subjects with history of or current hypercalcemia (serum calcium \> 10.5 mg/dL) or disease processes with underlying hypercalcemia pathology including hyperparathyroidism, nephrolithiasis, sarcoidosis, lung or bone malignancy
- Any subjects with diagnosis of Vitamin D deficiency or insufficiency, previously treated or currently treated with any form of prescription doses of either 1,25(OH)2D3 or 25(OH)D3 supplements exceeding 1000 IU/day
- Any subjects with malabsorption syndromes, nephrotic syndrome, or on medications that activate steroid or xenobiotic receptors which will interfere with absorption of Vitamin D supplements
- Any subjects with history of serious neurologic or psychiatric disorders that would interfere with the conduct or completion of the study
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01855321
Start Date
August 1 2010
End Date
March 1 2015
Last Update
June 26 2015
Active Locations (1)
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1
Shands Medical Plaza
Gainesville, Florida, United States, 32608