Harvey 2007.
Methods | RCT, 2 arms, individual randomisation. | |
Participants | 13 apparently healthy non‐anaemic non‐smokers pregnant women aged 18‐40 years and < 14 weeks of gestation with singleton pregnancy recruited through local medical practitioners and the Maternity Department of the Norfolk and Norwich University Hospital, England, United Kingdom. | |
Interventions | Participants were randomly assigned to 1 of 2 groups: group 1 received 100 mg elemental iron (as ferrous gluconate) daily after food and group 2 received a placebo. Supplementation started at 16th week of gestation until delivery. Setting and health worker cadre: The intervention was performed by midwives and obstetricians at Maternity Department of the Norfolk and Norwich University Hospital in Norwich, United Kingdom. |
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Outcomes | Maternal: Hb, serum ferritin, transferrin receptor, plasma zinc, exchangeable zinc pool, zinc excretion and zinc absorption at 16, 24 and 34 weeks of gestation. Infant: birthweight (not reported). | |
Notes | Unsupervised.
Compliance not reported. Gestational age at start of supplementation: early gestational age (supplementation started before 20 weeks' gestation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: higher daily dose (60 mg or more elemental iron). Iron release formulation: normal release preparation/unspecified. 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) | Low risk | Coded bottles were provided by manufacturer. |
Allocation concealment (selection bias) | Low risk | Supplied in coded opaque bottles. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as a single‐blind, placebo‐controlled trial. Placebo and active tablets were described as identical. Women blinded not clear that staff were. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators not blinded. Laboratory outcomes likely to be low risk of bias from blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |