Evidence map›Paper›PMID 29020329›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial.

Peter L Havens, Charles B Stephensen, Marta D Van Loan, Gertrud U Schuster, Leslie R Woodhouse, Patricia M Flynn, Catherine M Gordon, Cynthia G Pan, Brandy Rutledge, D Robert Harris and 8 more

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

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. 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 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
6.8field-weighted citation impact, top 2% 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.

NCT01751646 nacompletednot on this map

A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 50,000 IU Every 4 Weeks to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in Youth With HIV Infection Being Treated With Tenofovir-Containing Combination Antiretroviral Therapy (cART)

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2012 to 2016Enrolled214ConditionsHIV InfectionArmsVitamin D3 50,000 IU, Vitamin D3 placebo
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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 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. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Review
  14. Review
  15. Osteoporosis and HIV Infection.Calcified tissue international · 2022
    Review
  16. Article
  17. Review
  18. Bisphosphonates in Perinatally Infected Children and Adolescents With Human Immunodeficiency Virus: Targeting Puberty.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Article
  19. Article
  20. Observational
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

18 authors at 11 institutions in 1 country.

Peter L HavensDepartment of Pediatrics, Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee.
Charles B StephensenAgricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis.
Marta D Van LoanAgricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis.
Gertrud U SchusterDepartment of Nutrition, University of California, Davis.
Leslie R WoodhouseAgricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis.
Patricia M FlynnDepartment of Infectious Diseases, St Jude Children's Research Hospital, Memphis, Tennessee.
Catherine M GordonDepartment of Pediatrics, University of Cincinnati College of Medicine/Cincinnati Children's Hospital Medical Center, Ohio.
Cynthia G PanDepartment of Pediatrics, Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee.
Brandy RutledgeWestat, Rockville, Maryland.
D Robert HarrisWestat, Rockville, Maryland.
Georgine PriceWestat, Rockville, Maryland.
Alyne BakerTulane University of Health Sciences Center, New Orleans, Louisiana.
William A MeyerQuest Diagnostics, Baltimore, Maryland.
Craig M WilsonDepartment of Epidemiology, University of Alabama at Birmingham.
Rohan HazraMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Bill G KapogiannisMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Kathleen MulliganDepartment of Medicine, Division of Endocrinology, Zuckerberg San Francisco General Hospital, University of California, San Francisco.
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 109 Study Team
Agricultural Research Service · USSt. Jude Children's Research Hospital · USWestat (United States) · USChildren's Hospital of Wisconsin · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USCincinnati Children's Hospital Medical Center · USQuest Diagnostics (United States) · USSan Francisco General Hospital · USTulane University · USUniversity of Alabama at Birmingham · USUniversity of California, Davis · US

Funding

Adol. Medicine Trials Network for HIV/AIDS InterventionsU01HD040474 · NICHD · WESTAT, INC. · PI HARRIS, DONALD ROBERT · 2001 to 2016
$114.4M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
NCATS NIH HHS UL1 TR000170NICHD NIH HHS U01 HD040474NICHD NIH HHS U01 HD040533
6 · The paper itself

Abstract

Background: Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF. Methods: 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 <200 copies/mL, taking TDF-containing combination antiretroviral therapy (TDF-cART) for ≥180 days. Participants (N = 214) received a daily multivitamin containing VITD3 400 IU and calcium 162 mg, plus monthly randomized VITD3 50000 IU (n = 109) or placebo (n = 105). Outcome was change from baseline to week 48 in lumbar spine BMD (LSBMD). Data presented are median (Q1, Q3). Results: 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) <20 ng/mL. Multivitamin adherence was 49% (29%, 69%), and VITD3/placebo adherence 100% (100%, 100%). Vitamin D intake was 2020 (1914, 2168) and 284 (179, 394) IU/day, and serum 25-OHD concentration was 36.9 (30.5, 42.4) and 20.6 (14.4, 25.8) ng/mL at 48 weeks in VITD3 and placebo groups, respectively (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 <20 ng/mL (1.17% [-.82% to 2.90%]; P = .004) and ≥20 ng/mL (0.93% [-.26% to 2.15%]; P = .033). Conclusions: 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. Clinical Trials Registration: NCT01751646.

Indexed as

AdolescentAnti-HIV AgentsBone DensityBone Density Conservation AgentsCalcium-Regulating Hormones and AgentsCholecalciferolDouble-Blind MethodFemaleHIV InfectionsHumansMalePlacebosSpineTenofovirTreatment OutcomeYoung AdultAnti-HIV AgentsBone Density Conservation AgentsCalcium-Regulating Hormones and AgentsCholecalciferolPlacebosTenofovirbone mineral densityHIV infectionparathyroid hormonetenofovir disoproxil fumaratevitamin D supplementation

Identifiers

PMID29020329
PMCPMC5848310
OpenAlexW2791032589

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.