Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial
Overton ET, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Yin MT
Annals of internal medicine · 97 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute of Allergy and Infectious Diseases
- Gobierno
- NIAID NIH HHS
- Subvenciones
- National Institute of Allergy and Infectious Diseases (P30 AI045008); National Institute of Allergy and Infectious Diseases (U01AI069452); National Institute of Allergy and Infectious Diseases (K24AI120834); National Institute of Allergy and Infectious Diseases (UM1AI069534); National Institute of Allergy and Infectious Diseases (U01AI068636); National Institute of Allergy and Infectious Diseases (UM1-AI068634); National Institute of Allergy and Infectious Diseases (UM1AI069470)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2015-06-15 · Ann Intern Med · vol. 162 · número 12 · págs. 815–824
- Editorial
- American College of Physicians
- Citado
- 122 citas · más que el 100% de estudios similares · 18.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 52 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- HIV-related health complications and treatments · HIV/AIDS drug development and treatment · Vitamin D Research Studies
- Palabras clave
- vitamin D3, calcium supplementation, bone mineral density, bone loss, antiretroviral therapy initiation, HIV-1 infection, efavirenz, HIV-associated bone loss, 25-hydroxyvitamin D, hypercalcemia, kidney stones, AIDS Clinical Trials Group, total hip, lumbar spine, adverse events, drug-induced bone loss
- MeSH
- humans, hiv-1, hiv infections, osteoporosis, bone resorption, calcium carbonate, calcifediol, parathyroid hormone, anti-retroviral agents, absorptiometry, photon, prospective studies, double-blind method, bone density, dietary supplements, adult, middle aged, female, male, bone density conservation agents, biomarkers
10 autores
- Edgar Turner Overton🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Ellen S. Chan🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Todd Tarquin Brown🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Pablo Tebas🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Grace A. McComsey🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Kathleen M. Melbourne🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Andrew Napoli🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Bristol-Myers Squibb (United States); Case Western Reserve University; Columbia University
- William R. Hardin🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Heather Jane Ribaudo🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
- Michael T. Yin🇺🇸Johns Hopkins University; Duke University; Hospital of the University of Pennsylvania; Johns Hopkins Medicine; University of Alabama at Birmingham; Case Western Reserve University; Columbia University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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. (ClinicalTrials.gov: 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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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