Evidence map›Paper›PMID 24465617›Full record

Trial reportPloS one2014

Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV.

Louise Balfour, Johanna N Spaans, Dean Fergusson, Harold Huff, Edward J Mills, Charles J la Porte, Sharon Walmsley, Neera Singhal, Ron Rosenes, Nancy Tremblay and 9 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00798772 (A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT00798772 nacompletednot on this map

A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2009 to 2017Enrolled171ConditionsHIV InfectionArmsMicronutrients and antioxidants, Multivitamins and minerals
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Micronutrient supplementation in adults with HIV infection.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Article
  5. Article
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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

19 authors at 7 institutions in 1 country.

Louise BalfourCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Ottawa at the Ottawa Hospital, Ottawa, Ontario, Canada.
Johanna N SpaansCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Clinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
Dean FergussonClinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
Harold HuffCanadian College of Naturopathic Medicine, Toronto, Ontario, Canada.
Edward J MillsFaculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada.
Charles J la PorteDivision of Infectious Diseases, Department of Medicine, University of Ottawa at the Ottawa Hospital, Ottawa, Ontario, Canada ; Clinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
Sharon WalmsleyCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Neera SinghalCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Clinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
Ron RosenesCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada.
Nancy TremblayCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Ottawa at the Ottawa Hospital, Ottawa, Ontario, Canada.
M John GillCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Department of Microbiology, Immunology and Infectious Diseases, University of Calgary, Calgary, Alberta, Canada.
Hugues LoembaCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Department of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.
Brian ConwayCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada.
Anita RachlisCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Edward RalphCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Western Ontario, London, Ontario, Canada.
Mona LoutfyCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Ranjeeta MallickOttawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Rika MoorhouseClinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
D William CameronCIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Ottawa at the Ottawa Hospital, Ottawa, Ontario, Canada ; Clinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
HIV Legal Network · CAUniversity of Ottawa · CAOttawa Hospital · CAOttawa Hospital Research InstituteCanadian College of Naturopathic Medicine · CAUniversity of Toronto · CAWestern University · CA

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

introductionThe MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance (RDA) vitamins in slowing HIV immune deficiency progression in ART-naïve people with HIV infection.

objectiveWe planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates, as well as tolerance and adherence to study interventions.

methodsParticipants receive eight capsules twice daily of 1) high-dose or 2) RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression, safety and tolerability. Regression analysis was used to identify correlates of micronutrient levels at baseline. Adherence was measured by residual pill count, self-report using the General Treatment Scale (GTS) and short-term recall HIV Adherence Treatment Scale (HATS).

resultsPrior micronutrient supplementation (within 30 days) was 27% at screening and 10% of study population, and was not correlated with baseline micronutrient levels. Low levels were frequent for carotene (24%<1 nmol/L), vitamin D (24%<40 nmol/L) and serum folate (20%<15 nmol/L). The proportion with B12 deficiency (<133 pmol/L) was 2.4%. Lower baseline levels of B12 correlated lower baseline CD4 count (r = 0.21, p = 0.02) with a 21 pmol/L reduction in B12 per 100 cells/µL CD4. Vitamin D levels were higher in men (p<0.001). After a median follow-up of 1.63 years, there were 19 (15%) early withdrawals from the study treatment. Mean treatment adherence using pill count was 88%. Subjective adherence by the GTS was 81% and was moderately but significantly correlated with pill count (r = 0.29, p<0.001). Adherence based on short-term recall (HATS) was >80% in 75% of participants.

conclusionMicronutrient levels in asymptomatic HIV+ persons are in keeping with population norms, but micronutrient deficiencies are frequent. Adherence levels are high, and will permit a valid evaluation of treatment effects.

trial registrationClinicalTrials.gov NCT00798772.

Indexed as

Dietary SupplementsPatient ComplianceAdultAnti-HIV AgentsCarotenoidsCD4 Lymphocyte CountDietDisease ProgressionFemaleFolic AcidHIV InfectionsHumansMaleMicronutrientsMiddle AgedRecommended Dietary AllowancesAnti-HIV AgentsCarotenoidsFolic AcidMicronutrientsVitamin B 12Vitamin D

Identifiers

PMID24465617
PMCPMC3897458
OpenAlexW1997882566

What OpenQuestion holds

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LicenceCC BY
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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.