A prospective, randomized, placebo‐controlled trial of high‐dose vitamin D for prevention of vitamin D insufficiency in early stage chronic kidney disease

Objective Vitamin D insufficiency [25‐hydroxyvitamin D [25(OH)D] <30 ng/ml] is common in individuals with chronic kidney disease (CKD), even in the earlier stages. We aimed to determine if high‐dose vitamin D 3 could prevent vitamin D insufficiency in early stage CKD (stage 2 and 3). Methods : This was a prospective, randomized, controlled trial of vitamin D 3 (cholecalciferol 50,000 IU per wk for 12 wks followed by 50,000 IU every other wk for the remainder of the yr compared to placebo, ClinicalTrials.gov # NCT00781417). Serum 25(OH)D and PTH were measured at baseline, 12 wks, and 52 wks. Results 48 subjects were enrolled. At baseline, 57% of patients were vitamin D insufficient. In the vitamin D group, insufficiency rates decreased to 20% and 14% at 12 and 52 wks, respectively, and were lower (P<0.05) than the placebo group (77% and 47% at 12 and 52 wks, respectively). Mean serum 25(OH)D increased from 26.7 ± 6.8 to 42.8 ± 16.9 ng/ml in the D group at 12 wks (P<0.05) and remained elevated at 1 year. PTH decreased in the D group by 12 wks (−16.9 ± 30.3 pg/ml, P <0.05 ) . 25(OH)D or PTH did not change in the placebo group. Conclusions Our high‐dose vitamin D 3 treatment strategy for 1 yr was sufficient to improve and maintain optimal 25(OH)D concentrations in the majority of subjects with early stage CKD. Further study should assess the impact of early vitamin D therapy on other clinical outcomes. Grant Funding Source : Emory, Atlanta Veterans Affairs, T32 DK007298 ‐31