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L-arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis: A Randomised, Double-Blind, Placebo-Controlled Trial

Ralph, Anna P., Waramoi, Govert, Pontororing, Gysje J., Kenangalem, Enny, Wiguna, Andri, Tijitra, Emiliana, Sandjaja, Lolong, Dina B., Yeo, Tsin W., Chatfield, Mark D., Soemanto, Retno K., Bastian, Ivan, Lumb, Richard, Maguire, Graeme P., Eisman, John, Price, Ric N., Morris, Peter S., Kelly, Paul M. and Anstey, Nicholas M. (2013). L-arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis: A Randomised, Double-Blind, Placebo-Controlled Trial. PLoS One,8(8):e70032-1-e70032-12.

Document type: Journal Article
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IRMA ID bsmithxPUB187
NHMRC Grant No. 605806
496600
Title L-arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis: A Randomised, Double-Blind, Placebo-Controlled Trial
Author Ralph, Anna P.
Waramoi, Govert
Pontororing, Gysje J.
Kenangalem, Enny
Wiguna, Andri
Tijitra, Emiliana
Sandjaja
Lolong, Dina B.
Yeo, Tsin W.
Chatfield, Mark D.
Soemanto, Retno K.
Bastian, Ivan
Lumb, Richard
Maguire, Graeme P.
Eisman, John
Price, Ric N.
Morris, Peter S.
Kelly, Paul M.
Anstey, Nicholas M.
Journal Name PLoS One
Publication Date 2013
Volume Number 8
Issue Number 8
ISSN 1932-6203   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-84880929179
Start Page e70032-1
End Page e70032-12
Total Pages 12
Place of Publication United States of America
Publisher Public Library of Science
HERDC Category C1 - Journal Article (DIISR)
Abstract Background
Vitamin D (vitD) and L-arginine have important antimycobacterial effects in humans. Adjunctive therapy with these agents has the potential to improve outcomes in active tuberculosis (TB).

Methods
In a 4-arm randomised, double-blind, placebo-controlled factorial trial in adults with smear-positive pulmonary tuberculosis (PTB) in Timika, Indonesia, we tested the effect of oral adjunctive vitD 50,000 IU 4-weekly or matching placebo, and L-arginine 6.0 g daily or matching placebo, for 8 weeks, on proportions of participants with negative 4-week sputum culture, and on an 8-week clinical score (weight, FEV1, cough, sputum, haemoptysis). All participants with available endpoints were included in analyses according to the study arm to which they were originally assigned. Adults with new smear-positive PTB were eligible. The trial was registered at ClinicalTrials.gov NCT00677339.

Results
200 participants were enrolled, less than the intended sample size: 50 received L-arginine + active vitD, 49 received L-arginine + placebo vit D, 51 received placebo L-arginine + active vitD and 50 received placebo L-arginine + placebo vitD. According to the factorial model, 99 people received arginine, 101 placebo arginine, 101 vitamin D, 99 placebo vitamin D. Results for the primary endpoints were available in 155 (4-week culture) and 167 (clinical score) participants. Sputum culture conversion was achieved by week 4 in 48/76 (63%) participants in the active L-arginine versus 48/79 (61%) in placebo L-arginine arms (risk difference −3%, 95% CI −19 to 13%), and in 44/75 (59%) in the active vitD versus 52/80 (65%) in the placebo vitD arms (risk difference 7%, 95% CI −9 to 22%). The mean clinical outcome score also did not differ between study arms. There were no effects of the interventions on adverse event rates including hypercalcaemia, or other secondary outcomes.

Conclusion
Neither vitD nor L-arginine supplementation, at the doses administered and with the power attained, affected TB outcomes.

DOI http://dx.doi.org/10.1371/journal.pone.0070032   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 4.0 License
URL https://creativecommons.org/licenses/by/4.0/au/legalcode


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