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. 2015 Jul 22;2015(7):CD004736. doi: 10.1002/14651858.CD004736.pub5

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.
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.
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.