Evidence map›Paper›PMID 26075752›Full record

Trial reportAnnals of internal medicine2015

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

Edgar Turner Overton, Ellen S Chan, Todd T Brown, Pablo Tebas, Grace A McComsey, Kathleen M Melbourne, Andrew Napoli, William Royce Hardin, Heather J Ribaudo, Michael T Yin

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of internal medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 68 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 3 pooled it
17.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01403051 phase2completednot on this map

A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2011 to 2013Enrolled167ConditionsHIV-1 InfectionArmsEFV/FTC/TDF, Calcium Carbonate, Vitamin D3, Placebo for calcium carbonate, Placebo for vitamin D3
NCT05313477 phase4completednot on this mapstarted 2022, after this paper: background citation

The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate

TypeinterventionalSponsorMahidol UniversityRan2022 to 2023Enrolled64ConditionsParathyroid Hormone, Tenofovir Disoproxil Fumarate, Chronic Hepatitis B Virus, Vitamin DArmsErgocalciferol Capsules, Calcium carbonate
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 3 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. Diagnosis, prevention, and treatment of bone fragility in people living with HIV: a position statement from the Swiss Association against Osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Guideline
  3. Micronutrient supplementation in adults with HIV infection.The Cochrane database of systematic reviews · 2017
    Pooled it
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  15. A Single-dose Zoledronic Acid Infusion Prevents Antiretroviral Therapy-induced Bone Loss in Treatment-naive HIV-infected Patients: A Phase IIb Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Edgar Turner Overton
Ellen S Chan
Todd T Brown
Pablo Tebas
Grace A McComsey
Kathleen M Melbourne
Andrew Napoli
William Royce Hardin
Heather J Ribaudo
Michael T Yin
Bristol-Myers Squibb (Germany) · DE

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
Alabama-Clinical Trials UnitU01AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, MICHAEL S. · 2007 to 2011
$16.6M
Mentoring in Endocrine and Metabolic Abnormalities in HIV and AgingK24AI120834 · NIAID · JOHNS HOPKINS UNIVERSITY · PI BROWN, TODD T · 2015 to 2025
$1.8M
NIAID NIH HHS K24 AI120834NIAID NIH HHS P30 AI045008NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069452NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069534
6 · The paper itself

Abstract

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

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

design48-week prospective, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT01403051).

setting39 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.

results165 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.

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

Indexed as

Dietary SupplementsAbsorptiometry, PhotonAdultAnti-Retroviral AgentsBiomarkersBone DensityBone Density Conservation AgentsBone ResorptionCalcifediolCalcium CarbonateDouble-Blind MethodFemaleHIV-1HIV InfectionsHumansMaleAnti-Retroviral AgentsBiomarkersBone Density Conservation AgentsCalcifediolCalcium CarbonateParathyroid Hormone

Identifiers

PMID26075752
PMCPMC4608553
OpenAlexW1552487149

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.