Hurwitz 2007 USA.
Methods | Country: USA Setting: university clinic Duration of recruitment: June 2001 to July 2005 Duration of follow‐up: 9 months Design: randomized placebo controlled trial |
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Participants | Inclusion criteria: aged 18 to 55 years; no history of major systemic disorders related to HIV; premenopausal and not pregnant Exclusion criteria: on treatment for chronic conditions; selenium deficient Participants randomized: 310 Mean age = 40.5 years 179 male and 86 female Loss to follow‐up/withdrawal: 88 Exclusions postrandomization: 48 pretreatment |
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Interventions | Intervention: selenium (200 µg) Control: placebo Duration: daily for 9 months |
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Outcomes | Primary outcomes
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Adverse events | None | |
Notes | Participants on ART: 105/141 (74%) in selenium group; 87/121 (72%) in placebo group Preliminary analysis at 9 months of an 18‐month trial Source of funding: National Institutes of Health |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The trial used computerized block randomization. |
Allocation concealment (selection bias) | Unclear risk | The trial authors did not describe the method of allocation concealment used. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and investigators were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There were high unexplained losses to follow‐up, which were balanced between groups. The trial authors performed imputational analyses. |
Selective reporting (reporting bias) | High risk | The trial only reported data on main study outcomes for subgroups of participants (selenium responding versus non‐responding participants). |
Other bias | Low risk | The trial authors declared they had no conflicts of interest. |