Effect of vitamin D therapy on bone mineral density in patients with diabetic nephropathy; a randomized, double-blind placebo controlled clinical trial

Abstract

Purpose Diabetes compromises bone strength resulting increased risk of osteoporosis. Objective of this study was to determine the effect of vitamin D given to patients with early diabetic renal disease on BMD and BMC. Methods Patients with diabetic nephropathy were recruited. Treatment group received 50,000 IU of vitamin D3 intramuscularly and the control group was given an equal volume of distilled water (0.25 mL) monthly for six months. Baseline BMD, BMC in the total body, lumbar spine and proximal femur were measured by DXA. After six months measurements were repeated. When trial period was over, a randomly selected subgroup of patients (25 from each group) was followed up for further six-months and measurements were repeated. Results Selected patients were randomly assigned to two groups. After six months, the treatment group total body BMD, total body BMC and BMDs of spine, femoral neck and total hip regions increased by 2.0%, 2.2%, 1.8%, 2.1% and 2.6% (P < 0.05 for all within-group differences), respectively. In the Control group, BMD or BMC of any region mentioned above did not change significantly during the initial 6 months (P < 0.05 for the between-groups differences). After 6 months of stopping treatment, a statistically significant reduction of total BMD and BMC was observed in the treatment group (P = 0.009). Conclusion This study showed that treatment with high dose vitamin D significantly influences total body BMC, total body BMD, BMDs of spine, femoral neck and hip among patients with diabetic nephropathy.