Effect of High-Dose Vitamin D Repletion on Glycemic Control in African-American Males with Prediabetes and Hypovitaminosis D |
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| Institution: | 1. From the Section of Endocrinology, Department of Medicine, Jesse Brown VA Medical Center, Chicago, Illinois;2. Division of Endocrinology and Metabolism, Department of Medicine, University of Illinois, Chicago, Illinois.;1. Translational Research Institute for Metabolism and Diabetes, Florida Hospital, 301 East Princeton Street, Orlando, FL 32804, USA;2. Division of Endocrinology, Diabetes, and Metabolism, Tufts Medical Center, 800 Washington Street, Boston, MA 02111, USA;3. Sanford-Burnham-Prebys Medical Discovery Institute, 6400 Sanger Rd, Orlando, FL 32827, USA;4. Massachusetts Institute of Technology, Chemical Engineering Department Cambridge, MA 02142, USA;2. Cancer Center, Tufts Medical Center, 800 Washington St, Box 245, Boston, MA 02111, USA;3. Division of Endocrinology, Tufts Medical Center, 800 Washington Street, Box 268, Boston, MA 02111, USA;4. Kaiser Permanente Center for Health Research NW, 3800 N Interstate, Portland, OR 97229, USA;5. Kelly Government Services for the National Institute of Diabetes and Digestive and Kidney Diseases, 6701 Democracy Boulevard, Room 6107, Bethesda, MD 20817, USA;1. Department of Ophthalmology, King George''s Medical University, Lucknow, India;2. Department of Pharmacology, Employee''s State Insurance Corporation Medical College and Hospital, Haryana, India;3. Department of Ophthalmology, Faculty of Medicine, Comenius University and University Hospital, Bratislava, Slovakia;4. Clinic of Ophthalmology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Martin, Slovakia;5. Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Comenius University and University Hospital, Bratislava, Slovakia;6. Department of Internal Medicine, Brothers of Mercy Hospital, Brno, Czech Republic;7. 2nd Department of Surgery, Faculty of Medicine, St. Anne''s University Hospital, Brno, Czech Republic |
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| Abstract: | Objective: This double-blind, randomized, controlled trial evaluated whether 12 months of high-dose vitamin D2 supplementation improved insulin sensitivity and secretion and glycemic status.Methods: African-American males (AAM) with prediabetes (glycosylated hemoglobin A1C] 5.7-6.4%), hypovitaminosis D (25-hydroxyvitamin D 25OHD] 5-29 ng/mL), and prevalent medical problems were supplemented with vitamin D3 (400 IU/day) and then randomized to weekly placebo or vitamin D2 (50,000 IU). The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from an oral glucose tolerance test OGTT]) after 12 months of treatment. Secondary outcomes included other glycemic indices, A1C, and incident diabetes.Results: Baseline characteristics were similar in vitamin D-supplemented (n = 87) and placebo (n = 86) subjects completing the trial with average concentrations 14.4 ng/mL, 362 mL × min-1 × m-2, and 6.1% for 25OHD, OGIS and A1C, respectively. After 12 months, the vitamin D-supplemented group had a change in serum 25OHD +35 versus +6 ng/mL for placebo, P<.001; OGIS +7.8 versus -16.0 mL × min-1 × m-2 for placebo, P = .026; and A1C -0.01 versus +0.01% for placebo, P = .66. Ten percent of subjects in both groups progressed to diabetes. A posthoc analysis of participants with baseline impaired fasting glucose (IFG) showed that more subjects in the vitamin D subgroup (31.6%) than placebo (8.3%) returned to normal glucose tolerance, but the difference did not reach significance (P = .13).Conclusion: The trial does not provide evidence that 12 months of high-dose D2 repletion improves clinically relevant glycemic outcomes in subjects with prediabetes and hypovitaminosis D (NCT01375660).Abbreviations: AAM = African-American males A1C = glycosylated hemoglobin BMI = body mass index D2 = ergocalciferol D3 = cholecalciferol IFG = impaired fasting glucose IGT = impaired glucose tolerance JBVAMC = Jesse Brown VA Medical Center OGIS = oral glucose insulin sensitivity index OGTT = oral glucose tolerance test 25OHD = 25-hydroxyvitamin D VHA = Veterans Health Administration |
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