Cárcamo 2006 PER.
Methods | Country: Peru Setting: tertiary hospitals Duration of recruitment: June 1998 to Jan 2000 Duration of follow‐up: 2 weeks Design: randomized placebo‐controlled trial |
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Participants | Inclusion criteria: HIV‐seropositive, persistent diarrhoea (≥ 7 days) without prior treatment Exclusion criteria: none stated Participants randomized: 159 49 female and 110 male Median age = 30 years (range 19 to 57) in zinc group Median age = 31 years (range 19 to 64) in placebo group Loss to follow‐up/withdrawal: 51 Exclusions postrandomization: 0 |
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Interventions | Intervention: zinc sulphate (100 mg) Control: placebo Duration: daily for 14 days |
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Outcomes | Primary outcomes
Secondary outcomes:
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Adverse events | Gastrointestinal symptoms attributable to the medication (nausea, vomiting, abdominal pain) similar in both treatment groups | |
Notes | Sulfamethoxazole‐trimethoprim prescribed for participants with enteric bacterial pathogens (23 in zinc group and 12 in placebo) Source of funding: Fogarty IARTP grant; University of Washington Center for AIDS Research; Centers for Disease Control and Prevention (CDC) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The trial authors used computer‐generated blocked randomization. |
Allocation concealment (selection bias) | Low risk | The trial authors stated that the treatment allocators were unable to access the assignment roll. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and investigators were blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were high losses to follow‐up in both groups (34.6% intervention group versus 29.5% control group). |
Selective reporting (reporting bias) | Unclear risk | There was insufficient information; the trial protocol was unavailable. |
Other bias | Unclear risk | The trial authors did not declare on conflict of interest, if any. |