Kumwenda 2002.
Methods | RCT. | |
Participants | Inclusion criteria:
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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. |
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Outcomes | Primary outcome: maternal vitamin A levels in blood and breast milk and HIV transmission in mother and baby. Other outcomes: Hb and birthweight. |
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Notes | Vitamin A levels were measured before starting supplementation. Country: Malawi. Study setting: Queen Elizabeth Central Hospital (Blantyre, Malawi). |
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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. |