Semba 1995.
| Study characteristics | ||
| Methods | Individually randomised study in rural Indonesia | |
| Participants |
Eligibility: children aged 6 months at vaccination against measles Excluded: children who had measles previously Sample: 336 children. Baseline details on age and sex not provided |
|
| Interventions |
Experimental group: single‐dose vitamin A 100,000 IU Control group: placebo Vitamin A or placebo given with measles vaccine Study duration: 6 months |
|
| Outcomes | Measles | |
| Notes | Primary objective of study was to measure the antibody response to measles vaccine when given with vitamin A or placebo. Trialists found a significant decrease in seroconversion of measles vaccine in the vitamin A group compared to placebo. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Quote: "Treatment was assigned by random number table in blocks of ten". Comment: probably done. |
| Allocation concealment (selection bias) | Low risk |
Quote: "Infants received identification numbers as they were enrolled in the study, and each identification number had an envelope with an identical capsule containing either vitamin A or placebo". Comment: probably done. |
| Blinding (performance bias and detection bias) Blinding of participants | Low risk |
Quote: "Vitamin A, 100,000 IU, or placebo in identical capsules". Comment: probably done. |
| Blinding (performance bias and detection bias) Blinding of provider | Low risk |
Quote: "Infants received identification numbers as they were enrolled in the study, and each identification number had an envelope with an identical capsule containing either vitamin A or placebo". Comment: probably done. |
| Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Comment: as above; probably done. |
| Incomplete outcome data (attrition bias) | High risk |
Quote: "Follow‐up rates were 93% and 90% at one and six months post immunisation, respectively". Comment: the reasons for lost to follow‐up not given; only available‐case data given. |
| Selective reporting (reporting bias) | Unclear risk | Comment: study protocol not available. |
| Other bias | Unclear risk | Comment: inadequate information presented to assess this formally. |