Evidence map›Paper›PMID 25706751›Full record

Trial reportPloS one2015

Vitamin D₃supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial.

Andrew P Steenhoff, Joan I Schall, Julia Samuel, Boitshepo Seme, Marape Marape, Bakgaki Ratshaa, Irene Goercke, Michael Tolle, Maria S Nnyepi, Loeto Mazhani and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02189902 (Botswana Vitamin D Supplementation Study in HIV/AIDS), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
3.1field-weighted citation impact, top 9% 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.

NCT02189902 phase3completednot on this map

Botswana Vitamin D Supplementation Study in HIV/AIDS

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2012 to 2012Enrolled60ConditionsHIVArms4000 IU/d D3 over 12 weeks, 7000 IU/d D3 over 12 weeks
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Micronutrient supplementation in adults with HIV infection.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Effect of high dose vitamin DJournal of virus eradication · 2023
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  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

13 authors at 5 institutions in 2 countries.

Andrew P SteenhoffBotswana-UPenn Partnership, Gaborone, Botswana; Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America; Department of Pediatrics and Adolescent Health, School of Medicine, University of Botswana, Gaborone, Botswana.
Joan I SchallDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America.
Julia SamuelDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America.
Boitshepo SemeBotswana-UPenn Partnership, Gaborone, Botswana.
Marape MarapeBotswana-Baylor Children's Clinical Centre of Excellence, Gaborone, Botswana.
Bakgaki RatshaaBotswana-UPenn Partnership, Gaborone, Botswana.
Irene GoerckeBotswana-UPenn Partnership, Gaborone, Botswana.
Michael TolleBotswana-Baylor Children's Clinical Centre of Excellence, Gaborone, Botswana.
Maria S NnyepiDepartment of Nutrition, University of Botswana, Gaborone, Botswana.
Loeto MazhaniDepartment of Pediatrics and Adolescent Health, School of Medicine, University of Botswana, Gaborone, Botswana.
Babette S ZemelDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
Richard M RutsteinDivision of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
Virginia A StallingsDivision of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
Botswana Open University · BWChildren's Hospital of Philadelphia · USUniversity of Pennsylvania · USBotswana-Baylor Children's Clinical Center of Excellence · BWUniversity of Botswana · BW

Funding

INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
Institutional Clinical and Translational Science AwardUL1TR000003 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2012 to 2015
$38.9M
NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1TR000003NCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1RR024134
6 · The paper itself

Abstract

objectivesSince vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D).

designProspective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years.

methodsSixty subjects randomized within five age groups to either 4000 or 7000 IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32 ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores.

resultsSubjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9 ng/ml to 56±18 ng/ml (p<0.0001) and 68% and 90% had 25D ≥32 ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000 IU/d group (p<0.04). Younger (5-13y) and older (30-50y) subjects had greater Δ25D than those 14-29y (26±17 and 28±12 vs. 11±11 ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03).

conclusionsIn a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.

trial registrationClinicalTrials.gov NCT02189902.

Indexed as

AdolescentAdultBotswanaChildChild, PreschoolCholecalciferolDouble-Blind MethodFemaleHIV InfectionsHumansMaleMiddle AgedPilot ProjectsProspective StudiesTreatment OutcomeViral Load25-hydroxyvitamin DCholecalciferolVitamin D

Identifiers

PMID25706751
PMCPMC4338235
OpenAlexW2078316191

What OpenQuestion holds

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LicenceCC BY
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.