Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. (ECLIPSES)

Summary

Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the hypotheses are that an iron supplementation adapted to values of hemoglobin at the start of the pregnancy will would be more effective in preventing iron deficiency, without increasing the risk of hemoconcentration by the end of pregnancy. This would be helped optimize mother-child health status. The aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health. To accomplish this objective a Randomized Clinical Trial (RCT) triple-blinded was designed. The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation. Stratum 1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d. Stratum 2: If Hb \>130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d. This study will be conducted in non-anemic pregnant women at early gestation stage, and their subsequent newborns. The data recollected to mothers will be: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. In addition, biochemical measured will be Hemoglobin, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children, the data collected will be: ultrasound fetal biometry, anthropometric measurements, and temperament development Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice.

Timeline

Start

2013-07-10

Primary completion

2017-01-30

Completion

2017-01-30

Publications

• Background Aranda N, Ribot B, Garcia E, Viteri FE, Arija V. Pre-pregnancy iron reserves, iron supplementation during pregnancy, and birth weight. Early Hum Dev. 2011 Dec;87(12):791-7. doi: 10.1016/j.earlhumdev.2011.06.003. Epub 2011 Jun 30.
• Background Recommendations to prevent and control iron deficiency in the United States. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998 Apr 3;47(RR-3):1-29.
• Background Hernandez-Martinez C, Canals J, Aranda N, Ribot B, Escribano J, Arija V. Effects of iron deficiency on neonatal behavior at different stages of pregnancy. Early Hum Dev. 2011 Mar;87(3):165-9. doi: 10.1016/j.earlhumdev.2010.12.006. Epub 2011 Jan 22.
• Background Pena-Rosas JP, Viteri FE. Effects and safety of preventive oral iron or iron+folic acid supplementation for women during pregnancy. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004736. doi: 10.1002/14651858.CD004736.pub3.
• Background Ribot B, Aranda N, Viteri F, Hernandez-Martinez C, Canals J, Arija V. Depleted iron stores without anaemia early in pregnancy carries increased risk of lower birthweight even when supplemented daily with moderate iron. Hum Reprod. 2012 May;27(5):1260-6. doi: 10.1093/humrep/des026. Epub 2012 Feb 21.
• Kou X, Canals J, Arija V. Air pollution mixtures and cognitive outcomes in children: associations with school-age exposure and sex differences. Eur J Pediatr. 2026 Mar 19;185(4):192. doi: 10.1007/s00431-026-06841-6.
• Cendra-Duarte E, Canals J, Becerra-Tomas N, Mateu-Fabregat J, Bullo M, Arija V. Dietary glycemic index and load during pregnancy and offspring behavioral outcomes: exploring sex differences. Eur J Pediatr. 2025 Feb 6;184(2):178. doi: 10.1007/s00431-025-06005-y.
• Iglesias-Vazquez L, Gimeno M, Coronel P, Caspersen IH, Basora J, Arija V. Maternal factors associated with iron deficiency without anaemia in early pregnancy: ECLIPSES study. Ann Hematol. 2023 Apr;102(4):741-748. doi: 10.1007/s00277-023-05123-7. Epub 2023 Feb 15.

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