BACKGROUND: Previous trials of prenatal iron supplementation had limited measures of maternal or neonatal iron status. OBJECTIVE: The purpose was to assess effects of prenatal iron-folate supplementation on maternal and neonatal iron status. METHODS: Enrollment occurred June 2009 through December 2011 in Hebei, China. Women with uncomplicated singleton pregnancies at ≤20 wk gestation, aged ≥18 y, and with hemoglobin ≥100 g/L were randomly assigned 1:1 to receive daily iron (300 mg ferrous sulfate) or placebo + 0.40 mg folate from enrollment to birth. Iron status was assessed in maternal venous blood (at enrollment and at or near term) and cord blood. Primary outcomes were as follows: 1) maternal iron deficiency (ID) defined in 2 ways as serum ferritin (SF) <15 μg/L and body iron (BI) <0 mg/kg; 2) maternal ID anemia [ID + anemia (IDA); hemoglobin <110 g/L]; and 3) neonatal ID (cord blood ferritin <75 μg/L or zinc protoporphyrin/heme >118 μmol/mol). RESULTS:A total of 2371 women were randomly assigned, with outcomes for 1632 women or neonates (809 placebo/folate, 823 iron/folate; 1579 mother-newborn pairs, 37 mothers, 16 neonates). Most infants (97%) were born at term. At or near term, maternal hemoglobin was significantly higher (+5.56 g/L) for iron vs. placebo groups. Anemia risk was reduced (RR: 0.53; 95% CI: 0.43, 0.66), as were risks of ID (RR: 0.74; 95% CI: 0.69, 0.79 by SF; RR: 0.65; 95% CI: 0.59, 0.71 by BI) and IDA (RR: 0.49; 95% CI: 0.38, 0.62 by SF; RR: 0.51; 95% CI: 0.40, 0.65 by BI). Most women still had ID (66.8% by SF, 54.7% by BI). Adverse effects, all minor, were similar by group. There were no differences in cord blood iron measures; >45% of neonates in each group had ID. However, dose-response analyses showed higher cord SF with more maternal iron capsules reported being consumed (β per 10 capsules = 2.60, P < 0.05). CONCLUSIONS:Prenatal iron supplementation reduced anemia, ID, and IDA in pregnant women in rural China, but most women and >45% of neonates had ID, regardless of supplementation. This trial was registered at clinicaltrials.gov as NCT02221752.
RCT Entities:
BACKGROUND: Previous trials of prenatal iron supplementation had limited measures of maternal or neonatal iron status. OBJECTIVE: The purpose was to assess effects of prenatal iron-folate supplementation on maternal and neonatal iron status. METHODS: Enrollment occurred June 2009 through December 2011 in Hebei, China. Women with uncomplicated singleton pregnancies at ≤20 wk gestation, aged ≥18 y, and with hemoglobin ≥100 g/L were randomly assigned 1:1 to receive daily iron (300 mg ferrous sulfate) or placebo + 0.40 mg folate from enrollment to birth. Iron status was assessed in maternal venous blood (at enrollment and at or near term) and cord blood. Primary outcomes were as follows: 1) maternal iron deficiency (ID) defined in 2 ways as serum ferritin (SF) <15 μg/L and body iron (BI) <0 mg/kg; 2) maternal ID anemia [ID + anemia (IDA); hemoglobin <110 g/L]; and 3) neonatal ID (cord blood ferritin <75 μg/L or zinc protoporphyrin/heme >118 μmol/mol). RESULTS: A total of 2371 women were randomly assigned, with outcomes for 1632 women or neonates (809 placebo/folate, 823 iron/folate; 1579 mother-newborn pairs, 37 mothers, 16 neonates). Most infants (97%) were born at term. At or near term, maternal hemoglobin was significantly higher (+5.56 g/L) for iron vs. placebo groups. Anemia risk was reduced (RR: 0.53; 95% CI: 0.43, 0.66), as were risks of ID (RR: 0.74; 95% CI: 0.69, 0.79 by SF; RR: 0.65; 95% CI: 0.59, 0.71 by BI) and IDA (RR: 0.49; 95% CI: 0.38, 0.62 by SF; RR: 0.51; 95% CI: 0.40, 0.65 by BI). Most women still had ID (66.8% by SF, 54.7% by BI). Adverse effects, all minor, were similar by group. There were no differences in cord blood iron measures; >45% of neonates in each group had ID. However, dose-response analyses showed higher cord SF with more maternal iron capsules reported being consumed (β per 10 capsules = 2.60, P < 0.05). CONCLUSIONS: Prenatal iron supplementation reduced anemia, ID, and IDA in pregnant women in rural China, but most women and >45% of neonates had ID, regardless of supplementation. This trial was registered at clinicaltrials.gov as NCT02221752.
Authors: Tsunenobu Tamura; Robert L Goldenberg; Jinrong Hou; Kelley E Johnston; Suzanne P Cliver; Sharon L Ramey; Kathleen G Nelson Journal: J Pediatr Date: 2002-02 Impact factor: 4.406
Authors: Parul Christian; Laura E Murray-Kolb; Subarna K Khatry; Joanne Katz; Barbara A Schaefer; Pamela M Cole; Steven C Leclerq; James M Tielsch Journal: JAMA Date: 2010-12-22 Impact factor: 56.272
Authors: Jenni Bradley; Elizabeth A Leibold; Z Leah Harris; Jane D Wobken; Stephen Clarke; Kimberly B Zumbrennen; Richard S Eisenstein; Michael K Georgieff Journal: Am J Physiol Regul Integr Comp Physiol Date: 2004-06-03 Impact factor: 3.619
Authors: Ajibola I Abioye; Said Aboud; Zulfiqar Premji; Analee J Etheredge; Nilupa S Gunaratna; Christopher R Sudfeld; Robert Mongi; Laura Meloney; Anne Marie Darling; Ramadhani A Noor; Donna Spiegelman; Christopher Duggan; Wafaie Fawzi Journal: J Nutr Date: 2016-04-27 Impact factor: 4.798
Authors: Rosa M Angulo-Barroso; Ming Li; Denise C C Santos; Yang Bian; Julie Sturza; Yaping Jiang; Niko Kaciroti; Blair Richards; Betsy Lozoff Journal: Pediatrics Date: 2016-03-02 Impact factor: 7.124
Authors: Brian J Sandri; Jonathan Kim; Gabriele R Lubach; Eric F Lock; Candace Guerrero; LeeAnn Higgins; Todd W Markowski; Pamela J Kling; Michael K Georgieff; Christopher L Coe; Raghavendra B Rao Journal: Am J Physiol Regul Integr Comp Physiol Date: 2022-03-10 Impact factor: 3.210