Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF.
This was a randomized, double-blind, placebo-controlled trial of directly observed VITD3 vs placebo every 4 weeks for 48 weeks in youth aged 16–24 years with HIV, RNA load
Participants were aged 22.0 (21.0, 23.0) years, 84% were male, and 74% were black/African American. At baseline, 62% had 25-hydroxy vitamin D (25-OHD) P < .001). From baseline to week 48, LSBMD increased by 1.15% (−0.75% to 2.74%) in the VITD3 group (n = 99; P < .001) and 0.09% (−1.49% to 2.61%) in the placebo group (n = 89; P = .25), without between-group difference ( P = .12). VITD3 group changes occurred with baseline 25-OHD P = .004) and ≥20 ng/mL (0.93% [−.26% to 2.15%]; P = .033).
For youth taking TDF-cART, LSBMD increased through 48 weeks with VITD3 plus multivitamin, but not with placebo plus multivitamin, independent of baseline vitamin D status.
NCT01751646.