Evidence map›Paper›PMID 24709267›Full record

Trial reportAntimicrobial agents and chemotherapy2014

Nutritional supplementation increases rifampin exposure among tuberculosis patients coinfected with HIV.

Kidola Jeremiah, Paolo Denti, Emmanuel Chigutsa, Daniel Faurholt-Jepsen, George PrayGod, Nyagosya Range, Sandra Castel, Lubbe Wiesner, Christian Munch Hagen, Michael Christiansen and 4 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 6 pooled it
3.6field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 6 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
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  6. Nutritional supplements for people being treated for active tuberculosis.The Cochrane database of systematic reviews · 2016
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  20. Intrapulmonary Pharmacokinetics of First-line Anti-tuberculosis Drugs in Malawian Patients With Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    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

14 authors at 5 institutions in 3 countries.

Kidola JeremiahDepartment of Infectious Diseases, Odense University Hospital, Odense, Denmark National Institute for Medical Research, Mwanza Medical Research Centre, Mwanza, Tanzania jkidola@gmail.com.
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Emmanuel ChigutsaDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Daniel Faurholt-JepsenDepartment of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.
George PrayGodNational Institute for Medical Research, Mwanza Medical Research Centre, Mwanza, Tanzania.
Nyagosya RangeNational Institute for Medical Research, Muhimbili Research Centre, Dar Es Salaam, Tanzania.
Sandra CastelDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Christian Munch HagenDepartment of Clinical Biochemistry, Immunology and Genetics, Statens Serum Institut, Copenhagen, Denmark.
Michael ChristiansenDepartment of Clinical Biochemistry, Immunology and Genetics, Statens Serum Institut, Copenhagen, Denmark.
John ChangaluchaNational Institute for Medical Research, Mwanza Medical Research Centre, Mwanza, Tanzania.
Helen McIlleronDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Henrik FriisDepartment of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.
Aase Bengaard AndersenDepartment of Infectious Diseases, Odense University Hospital, Odense, Denmark.
University of Cape Town · ZANational Institute for Medical Research · TZStatens Serum Institut · DKUniversity of Copenhagen · DKOdense University Hospital · DK

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

Nutritional supplementation to tuberculosis (TB) patients has been associated with increased weight and reduced mortality, but its effect on the pharmacokinetics of first-line anti-TB drugs is unknown. A cohort of 100 TB patients (58 men; median age, 35 [interquartile range {IQR}, 29 to 40] years, and median body mass index [BMI], 18.8 [17.3 to 19.9] kg/m(2)) were randomized to receive nutritional supplementation during the intensive phase of TB treatment. Rifampin plasma concentrations were determined after 1 week and 2 months of treatment. The effects of nutritional supplementation, HIV, time on treatment, body weight, and SLCO1B1 rs4149032 genotype were examined using a population pharmacokinetic model. The model adjusted for body size via allometric scaling, accounted for clearance autoinduction, and detected an increase in bioavailability (+14%) for the patients in the continuation phase. HIV coinfection in patients not receiving the supplementation was found to decrease bioavailability by 21.8%, with a median maximum concentration of drug in serum (Cmax) and area under the concentration-time curve from 0 to 24 h (AUC0-24) of 5.6 μg/ml and 28.6 μg · h/ml, respectively. HIV-coinfected patients on nutritional supplementation achieved higher Cmax and AUC0-24 values of 6.4 μg/ml and 31.6 μg · h/ml, respectively, and only 13.3% bioavailability reduction. No effect of the SLCO1B1 rs4149032 genotype was observed. In conclusion, nutritional supplementation during the first 2 months of TB treatment reduces the decrease in rifampin exposure observed in HIV-coinfected patients but does not affect exposure in HIV-uninfected patients. If confirmed in other studies, the use of defined nutritional supplementation in HIV-coinfected TB patients should be considered in TB control programs. (This study has the controlled trial registration number ISRCTN 16552219.).

Indexed as

Dietary SupplementsAdultBiological AvailabilityBody Mass IndexBody WeightCohort StudiesCoinfectionFemaleGenotypeHIV InfectionsHumansMaleMiddle AgedRifampinTuberculosisWeight GainRifampin

Identifiers

PMID24709267
PMCPMC4068463
OpenAlexW1968940867

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.