Chisholm 1966.
Methods | RCT, 6 arms. | |
Participants | 360 non‐anaemic women attending antenatal clinic at Radcliffe Infirmary, Oxford, United Kingdom before 28th week of gestation, who had not taken iron supplements in the preceding 8 weeks and with Hb >= 102 g/L or a normal serum iron reading. Exclusion criteria: Hb < 110 g/L and serum iron less than 60 μg/L. | |
Interventions | Participants were randomly assigned to 1 of various combinations of elemental iron as ferrous gluconate and folic acid, as follows:
group 1: 900 mg elemental iron alone daily;
group 2: 900 mg elemental iron and 500 μg (0.5 mg) folic acid daily;
group 3: 900 mg elemental iron and 5000 μg (5 mg) folic acid daily;
group 4: placebo;
group 5: 500 μg (0.5 mg) folic acid daily;
group 6: 5000 μg (5 mg) of folic acid daily. Iron and folic acid placebos were used.
Supplementation started at 28th week until 40th week. Setting and health worker cadre: the intervention was performed by physicians at the antenatal clinic of The Radcliffe Infirmary, Oxford, United Kingdom. |
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Outcomes | Maternal: Hb, HCT, serum iron, serum folic acid activity, serum vitamin B12 estimation at 28 weeks of gestation and before delivery. | |
Notes | Unsupervised.
For purposes of this review, placebo group was the group who received neither iron nor folic acid. Groups 2 and 3 were merged for iron‐folic acid comparisons.
Compliance not reported. Gestational age at start of supplementation: late gestational age (from 28 weeks' gestation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: higher daily dose (60 mg or more of elemental iron). Iron release formulation: normal release preparation/not specified. Iron compound: ferrous gluconate. Malaria setting: non‐malarial setting. As of 2011: Malaria: no risk. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | External randomisation. |
Allocation concealment (selection bias) | Low risk | Bottles containing the tablets had been numbered by random selection at source and the code was unknown during trial. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind trial. Placebo‐controlled and placebo and active treatment described as indistinguishable. Bottles containing tablets were numbered and treatment allocation was not revealed until after the trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Women with anaemia were treated (irrespective or allocation). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up apparent. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |