Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT01855321
- Run by
- University of Florida
- People needed
- 76
- Starts
- 2010-08-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-06-26
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shands Medical Plaza — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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