Siega‐Riz 2001.
Methods | RCT, 2 arms with individual randomisation. | |
Participants | 429 non‐anaemic, iron replete women with less than 20 weeks of gestation attending who had not taken supplements containing iron in the last month, with a singleton pregnancy attending the prenatal clinic at the Wake County Human services in Raleigh, North Carolina, USA. | |
Interventions | Participants were randomly assigned to 1 of 2 groups: group 1 received multivitamin/mineral supplements containing 30 mg of iron (as ferrous sulphate) daily; group 2 received multivitamin/mineral supplements containing 0 mg of iron (no iron) until 29 weeks of gestation. Supplementation started on average at 12 weeks. The multivitamin/mineral supplement contained the following: 4000 IU vitamin A; 400 IU vitamin D; 70 mg vitamin C; 500 μg (0.5 mg) folic acid; 1.5 mg thiamine; 1.6 mg riboflavin; 17 mg niacin; 2.6 mg vitamin B6; 2.5 μg vitamin B1; 200 mg calcium; 100 mg magnesium; 1.5 mg copper; 15 mg zinc. Folic acid supplements were prescribed for all women who had received the positive pregnancy test until the first prenatal visit. Setting and health worker cadre: the intervention was performed by physicians at a clinic serving patients of a low socioeconomic group in Raleigh, North Carolina, United States of America. |
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Outcomes | Maternal: prevalence of anaemia, iron repletion and iron‐deficiency anaemia at 26‐29 weeks, side effects, compliance to treatment, iron status (Hb concentration, serum ferritin at 26‐29 weeks, preterm delivery. Infant: birthweight, proportion of low birthweight, small‐for‐gestational age. | |
Notes | Unsupervised.
Compliance measured by pill counts and a questionnaire and was 66% in the iron group and 63% in the control group. Compliance was also measured by the Medication Event Monitoring System (MEMS) in a subsample of 100 women. Gestational age at start of supplementation: early gestational age (less than 20 weeks' gestation at the start of supplementation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: lower daily dose (30 mg or less elemental iron daily). Iron release formulation: normal release preparation/unspecified. Iron compound:ferrous sulphate. 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 | By using random number generator. |
Allocation concealment (selection bias) | Low risk | Tretament provided in coded bottles by pharmacy. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blind, randomised trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk for laboratory outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | More than 20% lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |