| Methods |
RCT. Allocation by investigators not involved in other
aspects of the study. Investigators, parents and assessors blind to allocation |
| Participants |
28 children aged 6‐24 months with IDA (Hb < 10.5 g/dL and at least 2 abnormal measures of iron status) and 40 children without IDA (Hb > 12 g/dL) randomised. Volunteers invited to have iron screening from a community in Guatemala |
| Interventions |
Ferrous ascorbate 5 mg/kg body weight orally twice daily for 7 days or identical
placebo prepared by pharmacy and administered by researcher blind to allocation |
| Outcomes |
Bayley Scales of Infant Development administered pre and 6‐8 days post
commencement of intervention |
| Notes |
‐ |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Comment: no sufficient information provided |
| Allocation concealment (selection bias) |
Low risk |
Quote (from the report): "Both anaemic and nonanaemic infants were randomly assigned to oral iron or placebo treatment groups by investigators who did not participate in screening , testing" |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote (from correspondence): "Investigators, parents and assessors were blind to allocation" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote (from correspondence): "Investigators, parents and assessors were blind to allocation" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
0/15 (MDI) or 3/15 (PDI) missing from intervention group; 0/13 (PDI) or 1/13 (MDI) missing from control group. Missing outcome data almost balanced in numbers across groups |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes were reported |
