Evidence map›Paper›PMID 23151221›Full record

Trial reportBMC infectious diseases2012

Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial.

David Guwatudde, Amara E Ezeamama, Danstan Bagenda, Rachel Kyeyune, Fred Wabwire-Mangen, Henry Wamani, Ferdinand Mugusi, Donna Spiegelman, Molin Wang, Yukari C Manabe and 1 more

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

Trial report in BMC infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01228578 (Multi-vitamins, HAART and HIV/AIDS in Uganda), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT01228578 phase3completednot on this map

Multi-vitamins, HAART and HIV/AIDS in Uganda

TypeinterventionalSponsorHarvard School of Public Health (HSPH)Ran2010 to 2013Enrolled400ConditionsHIV/AIDSArmsMultivitamin supplements B,C and E
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Micronutrient supplementation in adults with HIV infection.The Cochrane database of systematic reviews · 2017
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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

11 authors at 4 institutions in 3 countries.

David GuwatuddeSchool of Public Health, Makerere University College of Health Sciences, PO Box 7072, Kampala, Uganda. dguwatudde@musph.ac.ug
Amara E Ezeamama
Danstan Bagenda
Rachel Kyeyune
Fred Wabwire-Mangen
Henry Wamani
Ferdinand Mugusi
Donna Spiegelman
Molin Wang
Yukari C Manabe
Wafaie W Fawzi
Harvard University · USMakerere University · UGInfectious Diseases Institute · UGMuhimbili University of Health and Allied Sciences · TZ

Funding

Multi-vitamins, HAART and HIV/AIDS in UgandaR01HD060333 · NICHD · HARVARD SCHOOL OF PUBLIC HEALTH · PI FAWZI, WAFAIE W · 2008 to 2012
$1.6M
NICHD NIH HHS R01 HD060333NICHD NIH HHS R01HD060333
6 · The paper itself

Abstract

backgroundUse of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. METHODS/

designWe are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. DISCUSSIONS: The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting.

trial registrationClinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578.

Indexed as

Clinical ProtocolsAdolescentAdultAntiretroviral Therapy, Highly ActiveBody WeightDietFemaleHIV InfectionsHumansLongitudinal StudiesMaleMiddle AgedPlacebosQuality of LifeTreatment OutcomeUgandaPlacebosVitamins

Identifiers

PMID23151221
PMCPMC3519743
OpenAlexW2141919711

What OpenQuestion holds

Textmetadata
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.