Evidence map›Paper›PMID 21215445›Full record

Trial reportLancet (London, England)2011

High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial.

Adrian R Martineau, Peter M Timms, Graham H Bothamley, Yasmeen Hanifa, Kamrul Islam, Alleyna P Claxton, Geoffrey E Packe, John C Moore-Gillon, Mathina Darmalingam, Robert N Davidson and 16 more

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

Trial report in Lancet (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 241 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
241citing papers in PubMed, 12 pooled it
48.9field-weighted citation impact, top 1% 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.

NCT00419068 phase3completednot on this map

Trial of Adjunctive Vitamin D in Tuberculosis Treatment

TypeinterventionalSponsorBarts & The London NHS TrustRan2007 to 2009Enrolled146ConditionsTuberculosis, PulmonaryArmsCholecalciferol, Migliol Placebo Oil
NCT02464683 phase4unknown statusnot on this mapstarted 2014, after this paper: background citation

Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis in the National Institute of Respiratory Diseases

TypeinterventionalSponsorInstituto Nacional de Enfermedades RespiratoriasRan2014 to 2016Enrolled60ConditionsPulmonary TuberculosisArmsVitaminD
NCT03984890 phase2 / phase3completednot on this mapstarted 2019, after this paper: background citation

Effect of Vitamin D3 Supplementation on Chronic Granulomatous Disease Patients With BCGosis/Itis

TypeinterventionalSponsorChildren's Hospital of Fudan UniversityRan2019 to 2023Enrolled50ConditionsVitamin D3, Chronic-granulomatous Disease, BCGArmsVitamin D3, Traditional treatment of CGD and TB
3 · Its place in the literature

Who cites it

241 citing papers in PubMed, 12 syntheses or guidelines pooled it, 574 citations in OpenAlex.

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  8. Nutritional supplements for people being treated for active tuberculosis.The Cochrane database of systematic reviews · 2016
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  18. Daily adjunctive therapy with vitamin DJournal of internal medicine · 2018
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  20. High-Dose Vitamin DAmerican journal of respiratory and critical care medicine · 2017
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181 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 12 institutions in 1 country.

Adrian R MartineauQueen Mary University of London, Barts and The London School of Medicine and Dentistry, London, UK. a.martineau@qmul.ac.uk
Peter M Timms
Graham H Bothamley
Yasmeen Hanifa
Kamrul Islam
Alleyna P Claxton
Geoffrey E Packe
John C Moore-Gillon
Mathina Darmalingam
Robert N Davidson
Heather J Milburn
Lucy V Baker
Richard D Barker
Nicholas J Woodward
Timothy R Venton
Korina E Barnes
Christopher J Mullett
Anna K Coussens
Clare M Rutterford
Charles A Mein
Geraint R Davies
Robert J Wilkinson
Vladyslav Nikolayevskyy
Francis A Drobniewski
Sandra M Eldridge
Christopher J Griffiths
Queen Mary University of London · GBHomerton University Hospital NHS Foundation Trust · GBBarts Health NHS Trust · GBGuy's and St Thomas' NHS Foundation Trust · GBKing's College Hospital · GBLondon Chest Hospital · GBNorthwick Park Hospital · GBRoyal London Hospital · GBThe Royal Free Hospital · GBUniversity Hospital Lewisham · GBUniversity of Liverpool · GBWhipps Cross University Hospital · GB

Funding

Medical Research Council G1000758Medical Research Council MC_U117588499Medical Research Council U117588499(88499)Wellcome Trust 072070Wellcome Trust 088316
6 · The paper itself

Abstract

backgroundVitamin D was used to treat tuberculosis in the pre-antibiotic era, and its metabolites induce antimycobacterial immunity in vitro. Clinical trials investigating the effect of adjunctive vitamin D on sputum culture conversion are absent.

methodsWe undertook a multicentre randomised controlled trial of adjunctive vitamin D in adults with sputum smear-positive pulmonary tuberculosis in London, UK. 146 patients were allocated to receive 2·5 mg vitamin D(3) or placebo at baseline and 14, 28, and 42 days after starting standard tuberculosis treatment. The primary endpoint was time from initiation of antimicrobial treatment to sputum culture conversion. Patients were genotyped for TaqI and FokI polymorphisms of the vitamin D receptor, and interaction analyses were done to assess the influence of the vitamin D receptor genotype on response to vitamin D(3). This trial is registered with ClinicalTrials.gov number NCT00419068.

findings126 patients were included in the primary efficacy analysis (62 assigned to intervention, 64 assigned to placebo). Median time to sputum culture conversion was 36·0 days in the intervention group and 43·5 days in the placebo group (adjusted hazard ratio 1·39, 95% CI 0·90-2·16; p=0.14). TaqI genotype modified the effect of vitamin D supplementation on time to sputum culture conversion (p(interaction)=0·03), with enhanced response seen only in patients with the tt genotype (8·09, 95% CI 1·36-48·01; p=0·02). FokI genotype did not modify the effect of vitamin D supplementation (p(interaction)=0·85). Mean serum 25-hydroxyvitamin D concentration at 56 days was 101·4 nmol/L in the intervention group and 22·8 nmol/L in the placebo group (95% CI for difference 68·6-88·2; p<0·0001).

interpretationAdministration of four doses of 2·5 mg vitamin D(3) increased serum 25-hydroxyvitamin D concentrations in patients receiving intensive-phase treatment for pulmonary tuberculosis. Vitamin D did not significantly affect time to sputum culture conversion in the whole study population, but it did significantly hasten sputum culture conversion in participants with the tt genotype of the TaqI vitamin D receptor polymorphism.

fundingBritish Lung Foundation.

Indexed as

AdultAntitubercular AgentsCholecalciferolDouble-Blind MethodFemaleHumansMalePolymorphism, GeneticReceptors, CalcitriolSputumTaq PolymeraseTuberculosis, PulmonaryVitaminsYoung AdultAntitubercular AgentsCholecalciferolReceptors, CalcitriolTaq PolymeraseVitamins

Identifiers

PMID21215445
PMCPMC4176755
OpenAlexW2157133006

What OpenQuestion holds

Textmetadata
LicenceTDM
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.