Simmons 1993.
Methods | RCT, 3 arms with individual randomisation | |
Participants | 376 pregnant women with ages between 16‐35 years, with mild anaemia (Hb concentrations between 80‐110 g/L) attending 8 maternal and child health centres in Kingston, St. Andrews and Spanish Town, Jamaica, with gestational age between 14‐22 weeks. | |
Interventions | Participants were randomly assigned to 1 of 3 groups: group 1 received 1 placebo tablet daily; group 2 received 100 mg of elemental iron (as ferrous sulphate) daily; group 3 received 50 mg of elemental iron (in a gastric delivery system capsule) daily. All women received 400 μg (0.4 mg) of folic acid. Setting and health worker cadre: the intervention was performed by clinic nurses and field workers at maternal and child health centres in urban areas of Jamaica. |
|
Outcomes | Hb, HCT, MCV, white cell count, serum iron, total iron binding capacity, serum ferritin, serum transferrin receptor, at baseline, at 6 weeks and at 12 weeks after start of supplementation as well as side effects. | |
Notes | Gestational ages differed in the participants and we have not included outcome data from this trial in the review. Gestational age at start of supplementation: mixed gestational age (up to 22 weeks' gestation at recruitment). Anaemic status at start of supplementation: anaemic at the start of supplementation (mild anaemia Hb 80‐110 g/L). Daily iron dose: mixed dose (medium dose group ‐ 50 mg elemental iron in gastric delivery system capsule; higher dose group 100 mg of elemental iron). Iron release formulation: gastric delivery system capsule (controlled release preparation). Iron compound: ferrous sulphate. Malaria setting: yes. As of 2011: very limited risk of P. falciparum malaria may occur in the Kingston St Andrew Parish. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | By random number table. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes distributed to clinics (not clear if envelopes were opaque). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Partial blinding. A placebo was provided but this was a single table while women in treatment groups received either 2 tablets or a capsule. It was stated that women were not told which preparations contained iron but staff would be aware of treatment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk for laboratory outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 376 women were recruited. 275 women were followed up (73.1%) but laboratory results were available for 66% of the original sample. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Low risk | The 3 groups were reported to have similar characteristics at baseline. |