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

PLoS ONE

Volumn 8, Issue 8, 2013, Pages

  Ralph, Anna P ^a,b   Waramori, Govert ^c   Pontororing, Gysje J ^a   Kenangalem, Enny ^a,d   Wiguna, Andri ^e   Tjitra, Emiliana ^f   Sandjaja, ^f   Lolong, Dina B ^f   Yeo, Tsin W ^a   Chatfield, Mark D ^a   Soemanto, Retno K ^g   Bastian, Ivan ^h   Lumb, Richard ^h   Maguire, Graeme P ^i,j   Eisman, John ^k   Price, Ric N ^a,b   Morris, Peter S ^a   Kelly, Paul M ^l   Anstey, Nicholas M ^a,b  

^a MENZIES SCHOOL OF HEALTH RESEARCH   (Australia)

^b ROYAL DARWIN HOSPITAL   (Australia)

^c Public Health and Malaria Control Department Papua   (Indonesia)

^d District Health Authority   (Indonesia)

^e District Health Authority ^*  (Indonesia)

^f NATIONAL INSTITUTE OF HEALTH RESEARCH AND DEVELOPMENT   (Indonesia)

^g UNIVERSITY OF INDONESIA   (Indonesia)

^h INSTITUTE OF MEDICAL AND VETERINARY SCIENCE   (Australia)

ⁱ JAMES COOK UNIVERSITY   (Australia)

^j BAKER IDI HEART AND DIABETES INSTITUTE   (Australia)

^k GARVAN INSTITUTE OF MEDICAL RESEARCH   (Australia)

^l ACT Health   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARGININE; ERGOCALCIFEROL; ETHAMBUTOL; ISONIAZID; PLACEBO; PYRAZINAMIDE; RIFAMPICIN; STREPTOMYCIN;

ADOLESCENT; ADULT; AGED; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; COUGHING; DIET SUPPLEMENTATION; DOUBLE BLIND PROCEDURE; FEMALE; FORCED EXPIRATORY VOLUME; HEMOPTYSIS; HUMAN; HYPERCALCEMIA; INDONESIA; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MORTALITY; NAUSEA; RANDOMIZED CONTROLLED TRIAL; SPUTUM CULTURE; TREATMENT OUTCOME; VOMITING;

ADOLESCENT; ADULT; AGED; ARGININE; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; MYCOBACTERIUM TUBERCULOSIS; NITRIC OXIDE; PLACEBOS; TREATMENT OUTCOME; TUBERCULOSIS, PULMONARY; VITAMIN D; YOUNG ADULT;

EID: 84880929179     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0070032     Document Type: Article

References (61)

1. Onyebujoh P, Rodriguez W, Mwaba P, (2006) Priorities in tuberculosis research. Lancet 367: 940-942.
2. Sinclair D, Abba K, Grobler L, Sudarsanam TD, (2011) Nutritional supplements for people being treated for active tuberculosis. Cochrane Database Syst Rev pp. CD006086.
3. Ralph AP, Kelly PM, Anstey NM, (2008) L-arginine and vitamin D: novel adjunctive immunotherapies in tuberculosis. Trends Microbiol 16: 336-344.
4. Liu PT, Stenger S, Li H, Wenzel L, Tan BH, et al. (2006) Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science 311: 1770-1773.
5. Fabri M, Stenger S, Shin DM, Yuk JM, Liu PT, et al. (2011) Vitamin D Is Required for IFN-gamma-Mediated Antimicrobial Activity of Human Macrophages. Sci Transl Med 3: 104ra102.
6. Martineau AR, Wilkinson RJ, Wilkinson KA, Newton SM, Kampmann B, et al. (2007) A Single Dose of Vitamin D Enhances Immunity to Mycobacteria. Am J Respir Crit Care Med.
7. Nnoaham KE, Clarke A, (2008) Low serum vitamin D levels and tuberculosis: a systematic review and meta-analysis. Int J Epidemiol 37: 113-119.
8. Gibney KB, MacGregor L, Leder K, Torresi J, Marshall C, et al. (2008) Vitamin D deficiency is associated with tuberculosis and latent tuberculosis infection in immigrants from sub-Saharan Africa. Clin Infect Dis 46: 443-446.
9. Davies P, (2010) Vitamin D and tuberculosis. Am J Respir Crit Care Med 181: 94.
10. Martineau AR, Timms PM, Bothamley GH, Hanifa Y, Islam K, et al. (2011) High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet 377: 242-250.
11. Wejse C, Gomes VF, Rabna P, Gustafson P, Aaby P, et al. (2009) Vitamin D as Supplementary Treatment for Tuberculosis- A Double-blind Randomized Placebo-controlled Trial. Am J Respir Crit Care Med.
12. Hmama Z, Sendide K, Talal A, Garcia R, Dobos K, et al. (2004) Quantitative analysis of phagolysosome fusion in intact cells: inhibition by mycobacterial lipoarabinomannan and rescue by an 1alpha,25-dihydroxyvitamin D3-phosphoinositide 3-kinase pathway. J Cell Sci 117: 2131-2140.
13. Yuk JM, Shin DM, Lee HM, Yang CS, Jin HS, et al. (2009) Vitamin D3 induces autophagy in human monocytes/macrophages via cathelicidin. Cell Host Microbe 6: 231-243.
14. Ralph AP, Lucas RM, Norval M, (2013) Vitamin D and solar ultraviolet radiation in the risk and treatment of tuberculosis. Lancet Infect Dis 13: 77-88.
15. Talat N, Perry S, Parsonnet J, Dawood G, Hussain R, (2010) Vitamin D deficiency and tuberculosis progression. Emerg Infect Dis 16: 853-855.
16. Martineau AR, Nanzer AM, Satkunam KR, Packe GE, Rainbow SJ, et al. (2009) Influence of a single oral dose of vitamin D(2) on serum 25-hydroxyvitamin D concentrations in tuberculosis patients. Int J Tuberc Lung Dis 13: 119-125.
17. Coussens AK, Wilkinson RJ, Hanifa Y, Nikolayevskyy V, Elkington PT, et al. (2012) Vitamin D accelerates resolution of inflammatory responses during tuberculosis treatment. Proc Natl Acad Sci U S A 109: 15449-15454.
18. Salahuddin N, Ali F, Hasan Z, Rao N, Aqeel M, et al. (2013) Vitamin D accelerates clinical recovery from tuberculosis: results of the SUCCINCT Study [Supplementary Cholecalciferol in recovery from tuberculosis]. A randomized, placebo-controlled, clinical trial of vitamin D supplementation in patients with pulmonary tuberculosis'. BMC Infect Dis 13: 22.
19. Holick MF, (2008) The vitamin D deficiency pandemic and consequences for nonskeletal health: mechanisms of action. Mol Aspects Med 29: 361-368.
20. Marwaha RK, Tandon N, Reddy DR, Aggarwal R, Singh R, et al. (2005) Vitamin D and bone mineral density status of healthy schoolchildren in northern India. Am J Clin Nutr 82: 477-482.
21. Wejse C, Olesen R, Rabna P, Kaestel P, Gustafson P, et al. (2007) Serum 25-hydroxyvitamin D in a West African population of tuberculosis patients and unmatched healthy controls. Am J Clin Nutr 86: 1376-1383.
22. Grant CC, Wall CR, Crengle S, Scragg R, (2009) Vitamin D deficiency in early childhood: prevalent in the sunny South Pacific. Public Health Nutr pp. 1-9.
23. Diamond TH, Eisman JA, Mason RS, Nowson CA, Pasco JA, (2005) Vitamin D and adult bone health in Australia and New Zealand: a position statement. Med J Aust 182: 281-285.
24. Diamond TH, Eisman JA, (2005) members of the Australian and New Zealand Bone and Mineral Society, Endocrine Society of Australia, and Osteoporosis Australia (2005) Vitamin D and adult bone health in Australia and New Zealand: a position statement. Med J Aust 182: 281-285.
25. Rizzoli R, Eisman JA, Norquist J, Ljunggren O, Krishnarajah G, et al. (2006) Risk factors for vitamin D inadequacy among women with osteoporosis: an international epidemiological study. Int J Clin Pract 60: 1013-1019.
26. Long R, Light B, Talbot JA, (1999) Mycobacteriocidal action of exogenous nitric oxide. Antimicrob Agents Chemother 43: 403-405.
27. Lugo-Villarino G, Verollet C, Maridonneau-Parini I, Neyrolles O, (2011) Macrophage polarization: convergence point targeted by mycobacterium tuberculosis and HIV. Front Immunol 2: 43.
28. Ralph AP, Yeo TW, Salome CM, Waramori G, Pontororing GJ, et al. (2013) Impaired pulmonary nitric oxide bioavailability in pulmonary tuberculosis: association with disease severity and delayed mycobacterial clearance with treatment. J Infect Dis accepted, Feb 2013.
29. Zea AH, Culotta KS, Ali J, Mason C, Park HJ, et al. (2006) Decreased expression of CD3zeta and nuclear transcription factor kappa B in patients with pulmonary tuberculosis: potential mechanisms and reversibility with treatment. J Infect Dis 194: 1385-1393.
30. Schon T, Elias D, Moges F, Melese E, Tessema T, et al. (2003) Arginine as an adjuvant to chemotherapy improves clinical outcome in active tuberculosis. Eur Respir J 21: 483-488.
31. Schon T, Idh J, Westman A, Elias D, Abate E, et al. (2011) Effects of a food supplement rich in arginine in patients with smear positive pulmonary tuberculosis-a randomised trial. Tuberculosis (Edinb) 91: 370-377.
32. Ardian M, Meokbun E, Siburian L, Malonda E, Waramori G, et al. (2007) A public-private partnership for TB control in Timika, Papua Province, Indonesia. Int J Tuberc Lung Dis 11: 1101-1107.
33. Pontororing GJ, Kenangalem E, Lolong DB, Waramori G, Sandjaja, et al, (2010) The burden and treatment of HIV in tuberculosis patients in Papua Province, Indonesia: a prospective observational study. BMC Infect Dis 10: 362.
34. World Weather Online: Timika weather. Available: http://www.worldweatheronline.com/Timika-weather/Nusa-Tenggara-Timur/ID.aspx. Accessed 2013 Jul 24.
35. Ralph AP, Ardian M, Wiguna A, Maguire GP, Becker NG, et al. (2010) A simple, valid, numerical score for grading chest x-ray severity in adult smear-positive pulmonary tuberculosis. Thorax 65: 863-869.
36. Gill M, Graff GR, Adler AJ, Dweik RA, (2006) Validation study of fractional exhaled nitric oxide measurements using a handheld monitoring device. J Asthma 43: 731-734.
37. American Thoracic Society (ATS), European Respiratory Society (ERS) (2005) ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med 171: 912-930.
38. Maguire GP, Anstey NM, Ardian M, Waramori G, Tjitra E, et al. (2009) Pulmonary tuberculosis, impaired lung function, disability and quality of life in a high-burden setting. Int J Tuberc Lung Dis 13: 1500-1506.
39. Jones PW, (2005) St. George's Respiratory Questionnaire: MCID. COPD 2: 75-79.
40. Lumb R, Ardian M, Waramori G, Syahrial H, Tjitra E, et al. (2006) An alternative method for sputum storage and transport for mycobacterium tuberculosis drug resistance surveys. Int J Tuberc Lung Dis 10: 172-177.
41. Byth K, Gebski V, (2004) Factorial designs: a graphical aid for choosing study designs accounting for interaction. Clin Trials 1: 315-325.
42. Guler M, Unsal E, Dursun B, Aydln O, Capan N, (2007) Factors influencing sputum smear and culture conversion time among patients with new case pulmonary tuberculosis. Int J Clin Pract 61: 231-235.
43. Telzak EE, Fazal BA, Pollard CL, Turett GS, Justman JE, et al. (1997) Factors influencing time to sputum conversion among patients with smear-positive pulmonary tuberculosis. Clin Infect Dis 25: 666-670.
44. Chang JM, Kuo MC, Kuo HT, Hwang SJ, Tsai JC, et al. (2004) 1-alpha,25-Dihydroxyvitamin D3 regulates inducible nitric oxide synthase messenger RNA expression and nitric oxide release in macrophage-like RAW 264.7 cells. J Lab Clin Med 143: 14-22.
45. Martineau AR, Wilkinson KA, Newton SM, Floto RA, Norman AW, et al. (2007) IFN-{gamma}- and TNF-Independent Vitamin D-Inducible Human Suppression of Mycobacteria: The Role of Cathelicidin LL-37. J Immunol 178: 7190-7198.
46. Boger RH, Bode-Boger SM, (2001) The clinical pharmacology of L-arginine. Annu Rev Pharmacol Toxicol 41: 79-99.
47. Lappe JM, Heaney RP, (2012) Why randomized controlled trials of calcium and vitamin D sometimes fail. Dermato-Endocrinology 4: 1-6.
48. Conesa-Botella A, Meintjes G, Coussens AK, van der Plas H, Goliath R, et al. (2012) Corticosteroid Therapy, Vitamin D Status, and Inflammatory Cytokine Profile in the HIV-Tuberculosis Immune Reconstitution Inflammatory Syndrome. Clin Infect Dis Jul 19 [Epub ahead of print].
49. Tostmann A, Wielders JP, Kibiki GS, Verhoef H, Boeree MJ, et al. (2010) Serum 25-hydroxy-vitamin D3 concentrations increase during tuberculosis treatment in Tanzania. Int J Tuberc Lung Dis 14: 1147-1152.
50. Narang NK, Gupta RC, Jain MK, (1984) Role of vitamin D in pulmonary tuberculosis. J Assoc Physicians India 32: 185-188.
51. Kharitonov SA, Lubec G, Lubec B, Hjelm M, Barnes PJ, (1995) L-arginine increases exhaled nitric oxide in normal human subjects. Clin Sci (Lond) 88: 135-139.
52. Yeo TW, Lampah DA, Gitawati R, Tjitra E, Kenangalem E, et al. (2007) Impaired nitric oxide bioavailability and L-arginine reversible endothelial dysfunction in adults with falciparum malaria. J Exp Med 204: 2693-2704.
53. Pessanha AP, Martins RA, Mattos-Guaraldi AL, Vianna A, Moreira LO, (2012) Arginase-1 expression in granulomas of tuberculosis patients. FEMS Immunol Med Microbiol Jul 25 [Epub ahead of print].
54. El Kasmi KC, Qualls JE, Pesce JT, Smith AM, Thompson RW, et al. (2008) Toll-like receptor-induced arginase 1 in macrophages thwarts effective immunity against intracellular pathogens. Nat Immunol 9: 1399-1406.
55. Vieth R, (2011) Vitamin D nutrient to treat TB begs the prevention question. Lancet 377: 189-190.
56. Grasemann H, Kurtz F, Ratjen F, (2006) Inhaled L-arginine improves exhaled nitric oxide and pulmonary function in patients with cystic fibrosis. Am J Respir Crit Care Med 174: 208-212.
57. Khan A, Sterling TR, Reves R, Vernon A, Horsburgh CR, (2006) Lack of weight gain and relapse risk in a large tuberculosis treatment trial. Am J Respir Crit Care Med 174: 344-348.
58. Yew WW, Leung CC, (2006) Prognostic significance of early weight gain in underweight patients with tuberculosis. Am J Respir Crit Care Med 174: 236-237.
59. Hoa NB, Lauritsen JM, Rieder HL, (2012) Changes in body weight and tuberculosis treatment outcome in Viet Nam. Int J Tuberc Lung Dis 1: 61-66.
60. Bernabe-Ortiz A, Carcamo CP, Sanchez JF, Rios J, (2011) Weight variation over time and its association with tuberculosis treatment outcome: a longitudinal analysis. PLoS ONE 6: e18474.
61. Vasantha M, Gopi PG, Subramani R, (2009) Weight gain in patients with tuberculosis treated under directly observed treatment short-course (DOTS). Indian J Tuberc 56: 5-9.