RESUMO
BACKGROUND: Vitamin D deficiency is associated with indicators of pre-diabetes including, insulin resistance, ß-cell dysfunction and elevated plasma glucose with controversial findings from current trials. This study aims to investigate the long-term effect of vitamin D on glucose metabolism and insulin sensitivity in pre-diabetic and highly vitamin-deficient subjects. METHODS: One hundred thirty-two participants were randomized to 30,000 IU vitamin D weekly for 6 months. Participants underwent oral glucose tolerance test (OGTT) at 3-month intervals to determine the change in plasma glucose concentration at 2 h after 75 g OGTT (2hPCG). Secondary measurements included glycated hemoglobin, fasting plasma glucose and insulin, post-prandial insulin, indices of insulin sensitivity (HOMA-IR, Matsuda Index), ß-cell function (HOMA-ß, glucose and insulin area under the curve (AUC), disposition and insulinogenic indices), and lipid profile. RESULTS: A total of 57 (vitamin D) and 75 (placebo) subjects completed the study. Mean baseline serum 25(OH) D levels were 17.0 ng/ml and 14.9 ng/ml for placebo and vitamin D group, respectively. No significant differences were observed for 2hPC glucose or insulin sensitivity indices between groups. HOMA-ß significantly decreased in the vitamin D group, while area under curve for glucose and insulin showed a significant reduction in ß-cell function in both groups. Additionally, HOMA-ß was found to be significantly different between control and treatment group and significance persisted after adjusting for confounding factors. CONCLUSION: Vitamin D supplementation in a pre-diabetic and severely vitamin-deficient population had no effect on glucose tolerance or insulin sensitivity. The observed reduction in ß-cell function in both placebo and vitamin D groups could be attributed to factors other than supplementation. TRIAL REGISTRATION: NCT02098980, 28/03/2014 (www.clinicaltrials.gov).
