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Efficacy and tolerability of low-dose iron supplements during pregnancy: a randomized controlled trial^1,2,3

¹ From the Child Nutrition Research Centre, Child Health Research Institute, and Department of Paediatrics, University of Adelaide, Women’s & Children’s Hospital, North Adelaide, Australia (MM); the Maternal Perinatal Clinical Trials Unit, Department of Obstetrics & Gynaecology, University of Adelaide, Women’s & Children’s Hospital, North Adelaide, Australia (MM and CAC); the Child Nutrition Research Centre, Child Health Research Institute and Department of Paediatrics & Child Health, Flinders Medical Centre, Bedford Park, Australia (RAG); and the Department of Human Nutrition, University of Otago, Dunedin, New Zealand (RSG and CMS).

Background: Iron deficiency anemia (IDA) is common in pregnant women, but previous trials aimed at preventing IDA used high-dose iron supplements that are known to cause gastrointestinal side effects.

Objective: The objective was to assess the effect on maternal IDA and iron deficiency (ID, without anemia) of supplementing pregnant women with a low dosage (20 mg/d) of iron. Effects on iron status were assessed at the time of delivery and at 6 mo postpartum. Gastrointestinal side effects were assessed at 24 and 36 wk of gestation.

Design: This was a randomized, double-blind, placebo-controlled trial of a 20-mg daily iron supplement (ferrous sulfate) given from 20 wk of gestation until delivery.

Results: A total of 430 women were enrolled, and 386 (89.7%) completed the follow-up to 6 mo postpartum. At delivery, fewer women from the iron-supplemented group than from the placebo group had IDA [6/198, or 3%, compared with 20/185, or 11%; relative risk (RR): 0.28; 95% CI: 0.12, 0.68; P < 0.005], and fewer women from the iron-supplemented group had ID (65/186, or 35%, compared with 102/176, or 58%; RR: 0.60; 95% CI: 0.48, 0.76; P < 0.001). There was no significant difference in gastrointestinal side effects between groups. At 6 mo postpartum, fewer women from the iron-supplemented group had ID (31/190, or 16%, compared with 51/177, or 29%; RR: 0.57; 95% CI: 0.38, 0.84; P < 0.005). The rate of IDA between the groups did not differ significantly at 6 mo postpartum.

Conclusion: Supplementing the diet of women with 20 mg Fe/d from week 20 of pregnancy until delivery is an effective strategy for preventing IDA and ID without side effects.

Key Words: Iron • pregnancy • iron deficiency • randomized controlled trial

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