Villamor 2008 TZA.

Methods	Country: Tanzania Setting: 5 outpatient tuberculosis clinics Duration of recruitment: April 2000 to April 2005 Median duration of follow‐up: 30 months (IQR 15 to 41) Design: randomized placebo‐controlled trial
Participants	Inclusion criteria: HIV‐positive and HIV‐negative adults aged 18 to 65 years with positive sputum smears for acid‐fast bacilli who planned to stay in Dar es Salaam for 2 years Exclusion criteria: pregnancy, antituberculosis treatment for > 4 weeks in previous year, Karnofsky score < 40% HIV‐positive participants randomized: 471 273 male and 198 female Mean age = 34 years Loss to follow‐up: 67 in HIV‐positive group (33 and 34 in micronutrient and placebo groups, respectively) Exclusions postrandomization: 0
Interventions	Intervention: micronutrient supplement (retinol; vitamins B1, B2, B6, B12; niacin; vitamin C; vitamin E; folic acid; selenium) Control: placebo Duration: daily for 24 months. All participants received DOTS antituberculosis chemotherapy.
Outcomes	Primary outcomes Culture negativity at 1 month after initiation of treatment; mortality during at least 24 months of follow‐up; tuberculosis recurrences. Secondary outcomes Changes from baseline in viral load, CD4 cell counts, and body weight.
Adverse events	None reported
Notes	Source of funding: National Institute of Allergy and Infectious Diseases; US Department of Agriculture
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The trial authors used computer‐generated permuted blocks of 20. Randomization was stratified by HIV status of participants.
Allocation concealment (selection bias)	Unclear risk	All clinical and research staff were unaware of the participants’ treatment assignment, but the trial authors provided insufficient information.
Blinding (performance bias and detection bias) All outcomes	Low risk	Participants and investigators were blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The trial authors did not provide reasons for losses to follow‐up, although they used appropriate statistical analyses.
Selective reporting (reporting bias)	Unclear risk	Insufficient information; the trial protocol was not available.
Other bias	Low risk	The trial authors declared that they had no conflicts of interest.