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. 2017 May 18;2017(5):CD003650. doi: 10.1002/14651858.CD003650.pub4

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
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
Interventions Intervention: 60 mg beta‐carotene
Control: placebo
Duration: 3 times daily for 4 weeks
Outcomes Primary outcomes
  • CD4 counts


Secondary outcomes
  • White blood cell count

  • Lymphocyte count

  • B‐lymphocytes

  • Serum beta‐carotene

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.
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.