A Randomized Placebo-Controlled Trial of Low- Versus Moderate-Dose Vitamin D3 Supplementation on Bone Mineral Density in Postmenopausal Women With HIV

Abstract

Background: Prevalence of osteoporosis and fracture is increased among older people with HIV. We compared the effects of Low (1000 IU) vs Moderate (3000 IU) Vitamin D 3 (VItD) supplementation on areal and volumetric bone mineral density (aBMD and vBMD) in African American and Hispanic postmenopausal women with HIV on antiretroviral therapy. Methods:We performed a 12-month prospective, randomized, double-blind, placebo-controlled study with primary outcomes of change in aBMD by dual-energy X-ray absorptiometry (DXA) and secondary outcomes of change in vBMD by quantitative computed tomography and bone turnover markers. An intent to treat analysis was performed on 85 randomized subjects (43 Low and 42 Moderate) for primary DXA outcomes, and complete case analysis performed for secondary outcomes.Results: Mean age was 56±5 years, median CD4 count 722 cells/mm 3 and 74% had HIV RNA≤50 copies/ml. Serum 25-OHD was higher in the Moderate than Low VitD group at 6 months (33.1±10.3 vs 27.8±8.1 ng/ml, p=0.03) and 12 months, but PTH levels remained similar. Percent change in aBMD, vBMD and bone turnover markers did not differ between Low and Moderate VitD groups before or after adjustment for baseline aBMD. Conclusion:VitD supplementation at 3000 IU daily increased mean total 25-OHD levels in postmenopausal women with HIV, but we did not find evidence of an effect on BMD beyond those observed with 1000 IU daily. Future studies are necessary to determine whether VitD Conflicts of Interest: MTY has served as a consultant for Gilead Sciences and Viiv. The other authors have no conflicts to declare.

Effect of Vitamin D3 and Calcium Carbonate Supplementation on Muscle Strength in Postmenopausal Women Living with HIV

“…We have previously published the results of a randomized clinical trial of two doses of VitD 3 repletion (3,000 IU versus 1,000 IU) on bone turnover and change in areal and volumetric bone mass and microarchitecture in minority postmenopausal women living with HIV [16]. We found changes in bone mineral density and bone microarchitecture did not differ between moderate and low VitD treatment groups.…”

“…Among all participants, 82 received at least one dose of the allocated intervention (41 in low VitD and 41 moderate VitD). Overall, 69 participants (31 in the low VitD and 38 in the moderate VitD groups) completed the 12-month study with complete muscle function and interpretable DXA data and were included in the complete-case analysis [16].…”

“…Participants were randomized in a 1:1 ratio using permuted blocks stratified by screening serum 25-OHD (≤20 and >20 ng/ml). Sample size for the main study was based upon the primary bone mineral density outcomes which have been reported [16]. Adherence to VitD and calcium was monitored by counts of returned pills at each 3-month study visit.…”

Implicaciones clínicas e inmunológicas de los micronutrientes durante la infección por VIH

“…Havens et al documentaron beneficios en DMO lumbar tras suplementar 50.000 UI / día de vitamina D durante 48 semanas, en conjunto con un multivitamínico que contenía 400 UI de vitamina D3 y 162 mg de calcio, esto en jóvenes de 16 -24 años con el VIH en TAR (51) . Yin et al evaluaron el impacto de la suplementación de 1,000 o 3,000 UI de vitamina D3 en mujeres posmenopáusicas infectadas con el VIH, documentando incremento en las concentraciones séricas de 25-OHD en el grupo que recibió 3,000 UI, sin efectos en la DMO tras 12 meses de suplementación (52) . Si bien algunos estudios han mostrado un efecto benéfico en la activación inmunológica tras la suplementación, los resultados con respecto a su impacto en la DMO son contradictorios debido a la heterogeneidad de las cohortes, por lo que aún no es posible dar recomendaciones claras para su suplementación en individuos VIH+.…”

Alcohol and Bone Turnover Markers among People Living with HIV and Substance Use Disorder

“…Abnormal levels of BTMs, independent of bone mineral density, are associated with higher fracture risk (Haskelberg et al, ; Vasikaran et al, ). Given these associations, BTMs are increasingly used to compare the effect of ARV medications on bone metabolism and to monitor the effectiveness of medications for osteoporosis (Bedimo et al, ; Haskelberg et al, ; Yin et al, ).…”