Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial.

TitleVitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial.
Publication TypeJournal Article
Year of Publication2015
AuthorsOverton ETurner, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WRoyce, Ribaudo HJ, Yin MT
JournalAnn Intern Med
Date Published2015 Jun 16
KeywordsAbsorptiometry, Photon, Adult, Anti-Retroviral Agents, Biomarkers, Bone Density, Bone Density Conservation Agents, Bone Resorption, Calcifediol, Calcium Carbonate, Dietary Supplements, Double-Blind Method, Female, HIV Infections, HIV-1, Humans, Male, Middle Aged, Osteoporosis, Parathyroid Hormone, Prospective Studies

BACKGROUND: Antiretroviral therapy initiation for HIV-1 infection is associated with 2% to 6% loss of bone mineral density (BMD).

OBJECTIVE: To evaluate the effect of vitamin D3 plus calcium supplementation on bone loss associated with antiretroviral therapy initiation.

DESIGN: 48-week prospective, randomized, double-blind, placebo-controlled study. ( NCT01403051).

SETTING: 39 AIDS Clinical Trials Group units.

PATIENTS: Adults with antiretroviral therapy-naive HIV.

MEASUREMENTS: BMD by dual-energy x-ray absorptiometry, 25-hydroxyvitamin D levels, and other laboratory assessments.

RESULTS: 165 eligible patients were randomly assigned (79 received vitamin D3 plus calcium and 86 received placebo). The study groups were well-balanced at baseline: 90% were men, 33% were non-Hispanic black, and the median CD4 count was 0.341 × 109 cells/L. At 48 weeks, the percentage of decline in total hip BMD was smaller in the vitamin D3 plus calcium group than in the placebo group: Medians were -1.36% (interquartile range [IQR], -3.43% to 0.50%) and -3.22% (IQR, -5.56% to -0.88%), respectively (P = 0.004). Similar results were seen at the lumbar spine. At 48 weeks, 90% of patients achieved HIV-1 RNA levels less than 50 copies/mL. Levels of 25-hydroxyvitamin D3 increased with vitamin D3 plus calcium but not with placebo: Median change was 61.2 nmol/L (IQR, 36.4 to 94.3) versus 1.7 nmol/L (IQR, -13.2 to 10.7) (P < 0.001). Overall, 103 patients (62%) reported 1 or more adverse event, with similar distribution between groups; no cases of hypercalcemia and 1 case of nephrolithiasis were reported in the placebo group.

LIMITATION: No international sites were included, and follow-up was only 48 weeks.

CONCLUSION: Vitamin D3 plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate.

Alternate JournalAnn. Intern. Med.
PubMed ID26075752
PubMed Central IDPMC4608553
Grant ListK24 AI120834 / AI / NIAID NIH HHS / United States
U01 AI069452 / AI / NIAID NIH HHS / United States
U01AI068636 / AI / NIAID NIH HHS / United States
UM1 AI068634 / AI / NIAID NIH HHS / United States
UM1 AI069534 / AI / NIAID NIH HHS / United States