Evidence map›Paper›PMID 24535626›Full record

Trial reportAntiviral therapy2014

Vitamin D3 supplementation increases fibroblast growth factor-23 in HIV-infected youths treated with tenofovir disoproxil fumarate.

Peter L Havens, Rohan Hazra, Charles B Stephensen, Jennifer J Kiser, Patricia M Flynn, Craig M Wilson, Brandy Rutledge, James Bethel, Cynthia G Pan, Leslie R Woodhouse and 8 more

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

Trial report in Antiviral therapy, 2014. 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 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 34% 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.

NCT00490412 nacompletednot on this map

Randomized, Placebo-controlled Trial of the Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in Adolescents and Young Adults With HIV Infection Being Treated With Antiretroviral Therapy Containing Tenofovir Compared to Those Being Treated With Antiretroviral Therapy Not Containing Tenofovir

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2007 to 2010Enrolled207ConditionsHIV InfectionsArmsVitamin D supplement, 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Effect of Cholecalciferol therapy on serum FGFJournal of endocrinological investigation · 2018
    Trial
  3. Trial
  4. Article
  5. 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 12 institutions in 1 country.

Peter L HavensChildren's Research Institute, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, WI, USA. phavens@mcw.edu.
Rohan Hazra
Charles B Stephensen
Jennifer J Kiser
Patricia M Flynn
Craig M Wilson
Brandy Rutledge
James Bethel
Cynthia G Pan
Leslie R Woodhouse
Marta D Van Loan
Nancy Liu
Jorge Lujan-Zilbermann
Alyne Baker
Bill G Kapogiannis
Catherine M Gordon
Kathleen Mulligan
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 study team
Westat (United States) · USAgricultural Research Service · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USMedical College of Wisconsin · USBrown University · USChildren's Hospital of Wisconsin · USFlorida College · USSt. Jude Children's Research Hospital · USTulane University · USUniversity of Alabama at Birmingham · USUniversity of Montana · USWestern Human Nutrition Research Center · US

Funding

Adol. Medicine Trials Network for HIV/AIDS InterventionsU01HD040474 · NICHD · WESTAT, INC. · PI HARRIS, DONALD ROBERT · 2001 to 2016
$114.4M
UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
ZOLENDRONIC ACID IN CHILDREN W/ SEVERE OSTEOGENESIS IMPERFECTAM01RR000188 · NCRR · BAYLOR COLLEGE OF MEDICINE · PI SHEARER, WILLIAM THOMAS · 1985 to 2011
$30.6M
World Trade Center Worker and Volunteer Medical Screening ProgramM01RR010710 · NCRR · STATE UNIVERSITY NEW YORK STONY BROOK · PI GOLDSTEIN, RITA Z · 1998 to 2009
$17.6M
ZAP-70 EXPRESSION, CD38 EXPRESSION AND PROGNOSIS IN CHRONIC LYMPHOCYTIC LEUKEMIAM01RR020359 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI HINDS, PAMELA S · 2005 to 2010
$13.8M
Tampa Bay Adolescent Medicine Trial UnitU01HD040497 · NICHD · UNIVERSITY OF SOUTH FLORIDA · PI EMMANUEL, PATRICIA J · 2001 to 2015
$7.3M
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEMSS10RR002517 · NCRR · GEORGETOWN UNIVERSITY · PI RAMWELL, PETER W · 1985 to 1985
–
Cancer Research UK RUL1-RR-024134NCATS NIH HHS UL1 TR002319NCRR NIH HHS M01 RR000188NCRR NIH HHS M01-RR00188NCRR NIH HHS M01 RR010710NCRR NIH HHS M01 RR020359NCRR NIH HHS M01RR020359NCRR NIH HHS M01-RR10710NCRR NIH HHS UL1 RR024131NCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1 RR025014NCRR NIH HHS UL1-RR025014NCRR NIH HHS UL1-RR02517NICHD NIH HHS U01 HD 040474NICHD NIH HHS U01 HD040474NICHD NIH HHS U01 HD040497NICHD NIH HHS U01 HD 040533NICHD NIH HHS U01 HD040533
6 · The paper itself

Abstract

backgroundTenofovir (TDF) is associated with phosphaturia and elevated 1,25 dihydroxy vitamin D (1,25-OH(2)D). Fibroblast growth factor 23 (FGF23) causes phosphaturia and increases in response to elevated 1,25-OH(2)D. Vitamin D-binding protein (VDBP) binds to 1,25-OH(2)D, decreasing its biological activity, and is elevated in individuals with higher plasma tenofovir concentrations. We compared FGF23 and VDBP before and after vitamin D3 (VITD) supplementation in youths treated with combination antiretroviral therapy (cART) containing or not containing TDF.

methodsA randomized controlled trial in HIV-positive youths aged 18-25 years enrolled participants based on cART treatment with TDF (TDF; n=118) or without TDF (no-TDF; n=85), and randomized within those groups to VITD (50,000 IU every 4 weeks) or placebo (PL). We measured FGF23 and VDBP and calculated free 1,25-OH(2)D at baseline and week 12, and compared changes by TDF treatment and VITD randomized group.

resultsAt baseline, serum FGF23 concentration showed a quadratic relationship with 1,25-OH(2)D most pronounced in the TDF group. At week 12, total and free 1,25-OH(2)D increased in the VITD but not PL groups, independent of TDF use. FGF23 increased in the TDF group receiving VITD, but there was no FGF23 change in the no-TDF group receiving VITD or the PL groups. The adjusted mean change in FGF23 from baseline to week 12 was 7.7 pg/ml in the TDF/VITD group, compared with -1.7 (no-TDF/VITD, P=0.010), -1.3 (TDF/PL, P=0.006) and 1.1 (no-TDF/PL, P=0.035).

conclusionsThese results suggest that TDF-containing cART may alter the FGF23 response to vitamin D supplementation in HIV-infected youths. Clinical trials number: NCT00490412.

Indexed as

Dietary SupplementsAdenineAdolescentAdultAnti-HIV AgentsCholecalciferolFemaleFibroblast Growth Factor-23Fibroblast Growth FactorsHIV InfectionsHumansMaleOrganophosphonatesReverse Transcriptase InhibitorsTenofovirTreatment OutcomeAdenineAnti-HIV AgentsCholecalciferolFGF23 protein, humanFibroblast Growth Factor-23Fibroblast Growth FactorsOrganophosphonatesReverse Transcriptase InhibitorsTenofovir

Identifiers

PMID24535626
PMCPMC4135028
OpenAlexW2056185486

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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.