Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. diagnosis of type 2 diabetes (per ADA criteria), on antihyperglycemic medications for at least 6 months and

2. HbAlc value of 7.5%-10% 7-12%for at least 3 months prior to screening, and

3. 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

4. on either angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blockade (ARB) antihypertensive medication

Exclusion Criteria:

1. Any subjects with history of end-stage renal disease or frank proteinuria on urinalysis

2. Any subjects with pregnancy at time of screening

3. 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

4. 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

5. 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

6. Any subjects with history of serious neurologic or psychiatric disorders that would interfere with the conduct or completion of the study