Coodley 1993 USA.
Methods | Country: USA Setting: hospital outpatient clinics Duration of recruitment: not stated Duration of follow‐up: 8 weeks Design: randomized cross‐over trial; no washout period |
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Participants | Inclusion criteria: HIV‐seropositive Exclusion criteria: on other forms of vitamin A supplementation; significant hepatic or renal dysfunction; active opportunistic infection or fever Participants randomized: 21 20 male and 1 female Median age: not stated Loss to follow‐up/withdrawal: 4 Exclusions postrandomization: 0 |
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Interventions | Intervention: 60 mg beta‐carotene Control: placebo Duration: 3 times daily for 4 weeks |
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Outcomes | Primary outcomes
Secondary outcomes
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Adverse events | No toxicity; skin discolouration in treatment group | |
Notes | CD4 count data reported as means and ranges 16 participants received ART. Source of funding: Hoffman La Roche Inc. |
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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 the method of random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | The trial authors did not describe the method of allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and investigators were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition at 1 month; the trial authors provided reasons. |
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. |