Burbano 2002 USA.
Methods | Country: USA Setting: community‐based clinic Duration of recruitment: 1998 to 2000 Duration of follow‐up: 12 months Design: randomized placebo‐controlled trial |
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Participants | Inclusion criteria: confirmed HIV, past or present use of illegal drugs, ≥ 18 years, adequate selenium status (> 85 µg/L) Exclusion criteria: selenium deficient (< 85 µg/L) Participants randomized: 259 112 female Median age = 40 years (range 24 to 54) Loss to follow‐up/withdrawal: 73 at 12 months Exclusions postrandomization: 0 |
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Interventions | 200 microgram selenium or placebo daily for 12 months. | |
Outcomes | Primary outcomes
Secondary outcomes
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Adverse events | None reported | |
Notes | Number of participants on ART:
Selenium group: 64 (76%)
Control group: 60 (53%) Number, type, and duration of hospital admissions recorded 2 years prior and during study period. Medical records reviewed by team of physicians. Source of funding: research grant and commercial (materials) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial authors did not describe how they performed sequence generation. |
Allocation concealment (selection bias) | Unclear risk | The trial authors did not describe how they performed allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and investigators were blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Exclusions from the analysis (73/259 (28%)) not reported by treatment group. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information; the trial protocol was unavailable |
Other bias | Unclear risk | The trial authors did not declare on any conflicts of interest, if any. |