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. 2015 Oct 27;2015(10):CD008666. doi: 10.1002/14651858.CD008666.pub3

Kumwenda 2002.

Methods RCT.
Participants Inclusion criteria:
  • pregnant women of 18‐28 weeks’ gestation;

  • HIV‐positive women.

Interventions Intervention group: 340 women received daily doses of orally administered vitamin A (3 mg retinol equivalent (10,000 IU of vitamin A) + iron and folate for minimum of 12 weeks. Oral vitamin A (30 mg retinol equivalent) at 6 weeks' postpartum.
Control group: 357 women received daily doses of iron (30 mg of elemental iron) and folate (400 mg) from the time of study enrolment until delivery. Oral vitamin A (30 mg retinol equivalent) at 6 weeks postpartum.
Outcomes Primary outcome: maternal vitamin A levels in blood and breast milk and HIV transmission in mother and baby.
Other outcomes: Hb and birthweight.
Notes Vitamin A levels were measured before starting supplementation.
Country: Malawi.
Study setting: Queen Elizabeth Central Hospital (Blantyre, Malawi).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "a computer random‐number generator."
Allocation concealment (selection bias) Low risk "pre packing study supplements in sequentially numbered series assigned to study identification numbers."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and personnel "Double blind".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information given.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 63 (9%) women were excluded from the analysis: 57 moved out, 6 could not be located.
Selective reporting (reporting bias) Unclear risk The protocol of the study is not available at the moment.
Other bias Low risk Not aware of any other bias.