Evidence map›Paper›PMID 22267714›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial.

Peter L Havens, Charles B Stephensen, Rohan Hazra, Patricia M Flynn, Craig M Wilson, Brandy Rutledge, James Bethel, Cynthia G Pan, Leslie R Woodhouse, Marta D Van Loan and 6 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. 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 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

45 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Micronutrient supplementation in adults with HIV infection.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Associations between vitamin D metabolites, antiretroviral therapy and bone mineral density in people with HIV.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016
    Trial
  8. Trial
  9. Increased bone resorption during tenofovir plus lopinavir/ritonavir therapy in Chinese individuals with HIV.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Article
  16. Article
  17. Review
  18. Osteoporosis and HIV Infection.Calcified tissue international · 2022
    Review
  19. Review
  20. Article
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

16 authors.

Peter L HavensDepartment of Pediatrics, Children's Research Institute, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, WI 53201-1997, USA. phavens@mcw.edu
Charles B Stephensen
Rohan Hazra
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
Kathleen Mulligan
Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions 063 study team

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
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 LOUIS, CHRYSTAL U · 1985 to 2011
$30.6M
World Trade Center Worker and Volunteer Medical Screening ProgramM01RR010710 · NCRR · STATE UNIVERSITY NEW YORK STONY BROOK · PI CHEN, WEN Y · 1998 to 2009
$17.6M
ZAP-70 EXPRESSION, CD38 EXPRESSION AND PROGNOSIS IN CHRONIC LYMPHOCYTIC LEUKEMIAM01RR020359 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI RAKHMANINA, NATELLA Y · 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
–
NCRR 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-RR-024134NCRR 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 HD040533PHS HHS U01 A1068632
6 · The paper itself

Abstract

backgroundThe study goal was to determine the effect of vitamin D (VITD) supplementation on tubular reabsorption of phosphate (TRP), parathyroid hormone (PTH), bone alkaline phosphatase (BAP), and C-telopeptide (CTX) in youth infected with human immunodeficiency virus (HIV) receiving and not receiving combination antiretroviral therapy (cART) containing tenofovir disoproxil fumarate (TDF).

methodsThis randomized, double-blind, placebo-controlled multicenter trial enrolled HIV-infected youth 18-25 years based on stable treatment with cART containing TDF (n = 118) or no TDF (noTDF; n = 85), and randomized within those groups to vitamin D3, 50 000 IU (n = 102) or placebo (n = 101), administered at 0, 4, and 8 weeks. Outcomes included change in TRP, PTH, BAP, and CTX from baseline to week 12 by TDF/noTDF; and VITD/placebo.

resultsAt baseline, VITD and placebo groups were similar except those on TDF had lower TRP and higher PTH and CTX. At week 12, 95% in the VITD group had sufficient serum 25-hydroxy vitamin D (25-OHD; ≥20 ng/mL), increased from 48% at baseline, without change in placebo (P < .001). PTH decreased in the TDF group receiving VITD (P = .031) but not in the noTDF group receiving VITD, or either placebo group. The decrease in PTH with VITD in those on TDF occurred with insufficient and sufficient baseline 25-OHD (mean PTH change, -7.9 and -6.2 pg/mL; P = .031 and .053, respectively).

conclusionsIn youth on TDF, vitamin D3 supplementation decreased PTH, regardless of baseline 25-OHD concentration. CLINICAL TRIALS REGISTRATION: NCT00490412.

Indexed as

AdenineAdolescentAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCholecalciferolDouble-Blind MethodDrug InteractionsFemaleHIV InfectionsHumansMaleMulticenter Studies as TopicOrganophosphonatesParathyroid HormonePlacebosTenofovirAdenineAnti-HIV AgentsCholecalciferolOrganophosphonatesParathyroid HormonePlacebosTenofovirVitamins

Identifiers

PMID22267714
PMCPMC3297650

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.