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Iron Supplementation in Pregnancy or Infancy and Motor Development: A Randomized Controlled Trial.

ABSTRACT: BACKGROUND AND OBJECTIVE:Insufficient iron levels for optimal fetal and infant development is a concern during pregnancy and infancy. The goal of this study was to assess the effects of iron supplementation in pregnancy and/or infancy on motor development at 9 months. METHODS:The study was a randomized controlled trial (RCT) of infancy iron supplementation linked to an RCT of pregnancy iron supplementation, conducted in Hebei, China. A total of 1482 infants were randomly assigned to receive placebo (n = 730) or supplemental iron (n = 752) from 6 weeks to 9 months. Gross motor development (assessed by using the Peabody Developmental Motor Scale, Second Edition, instrument) was the primary outcome. Neurologic integrity and motor quality were secondary outcomes. RESULTS:Motor outcome was available for 1196 infants, divided into 4 supplementation period groups: (1) placebo in pregnancy/placebo in infancy (n = 288); (2) placebo in pregnancy/iron in infancy (n = 305); (3) iron in pregnancy/placebo in infancy (n = 298); and (4) iron in pregnancy/iron in infancy (n = 305). Using the Peabody Developmental Motor Scale, instrument, iron supplementation in infancy but not pregnancy improved gross motor scores: overall, P < .001; reflexes, P = .03; stationary, P < .001; and locomotion, P < .001. Iron supplementation in infancy improved motor scores by 0.3 SD compared with no supplementation or supplementation during pregnancy alone. Effects of iron supplementation in infancy alone were similar to effects with iron in both pregnancy and infancy. CONCLUSIONS:The RCT design supports the causal inference that iron supplementation in infancy, with or without iron supplementation in pregnancy, improved gross motor test scores at 9 months.

SUBMITTER: Angulo-Barroso RM

PROVIDER: S-EPMC4811316 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Iron Supplementation in Pregnancy or Infancy and Motor Development: A Randomized Controlled Trial.

Angulo-Barroso Rosa M RM Li Ming M Santos Denise C C DC Bian Yang Y Sturza Julie J Jiang Yaping Y Kaciroti Niko N Richards Blair B Lozoff Betsy B

Pediatrics 20160302 4

<h4>Background and objective</h4>Insufficient iron levels for optimal fetal and infant development is a concern during pregnancy and infancy. The goal of this study was to assess the effects of iron supplementation in pregnancy and/or infancy on motor development at 9 months.<h4>Methods</h4>The study was a randomized controlled trial (RCT) of infancy iron supplementation linked to an RCT of pregnancy iron supplementation, conducted in Hebei, China. A total of 1482 infants were randomly assigned ...[more]

PMID: 26936859

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Project description:BackgroundBeyond perinatal folic acid supplementation, the need for additional prenatal prophylaxis of iron with or without other micronutrients remains unclear. We aim to investigate the maternal and infant health effects of iron plus folic acid and multiple micronutrient supplements vs folic acid alone when provided to pregnant women with no or mild anemia.MethodsIn this randomized double-blind controlled trial, 18,775 nulliparous pregnant women with mild or no anemia were enrolled from 5 counties of northern China from May 2006 through April 2009. Women were randomly assigned to daily folic acid (400 μg) (control), folic acid-iron (30 mg), or folic acid, iron, and 13 additional vitamins and minerals provided before 20 weeks gestation to delivery. Primary outcome was perinatal mortality. Secondary outcomes included neonatal and infant mortality, preterm delivery, birth weight, birth length, gestational duration, and maternal hemoglobin concentration and anemia.ResultsA total of 92.7% of women consumed 80% to 100% of supplements as instructed. On average, women consumed 177 supplements. Compared with daily prenatal folic acid, supplementation with iron-folic acid with or without other micronutrients did not affect the rate of perinatal mortality (8.8, 8.7, and 8.3, respectively) per 1000 births, and relative risks (RRs) were 1.00 (95% CI, 0.68-1.46; P = .99) and 0.94 (95% CI, 0.64-1.39; P = .76), respectively. Risk of other adverse maternal and infant outcomes also did not differ, except that RRs for third-trimester maternal anemia were 0.72 (95% CI, 0.63-0.83; P < .001) and 0.71 (95% CI, 0.62-0.82; P < .001), respectively.ConclusionPrenatal iron-folic acid and other micronutrient supplements provided to Chinese women with no or mild anemia prevented later pregnancy anemia beyond any benefit conferred by folic acid alone but did not affect perinatal mortality or other infant outcomes.Trial registrationclinicaltrials.gov Identifier: NCT00133744.

Project description:ObjectivePreconception micronutrient interventions may be a promising approach to reduce anemia and iron deficiency during pregnancy, but currently we have limited data to inform policies. We evaluated whether providing additional pre-pregnancy weekly iron-folic acid (IFA) or multiple micronutrient (MM) supplements compared to only folic acid (FA) improves iron status and anemia during pregnancy and early postpartum.MethodsWe conducted a double blind randomized controlled trial in which 5011 Vietnamese women were provided with weekly supplements containing either only 2800 μg FA (control group), IFA (60 mg Fe and 2800 μg FA) or MM (15 micronutrients with similar amounts of IFA). All women who became pregnant (n = 1813) in each of the 3 groups received daily IFA (60 mg Fe and 400 μg FA) through delivery. Hematological indicators were assessed at baseline (pre-pregnancy), during pregnancy, 3 months post-partum, and in cord blood. Adjusted generalized linear models were applied to examine the impact of preconception supplementation on anemia and iron stores, using both intention to treat and per protocol analyses (women consumed supplements ≥ 26 weeks before conception).ResultsAt baseline, 20% of women were anemic, but only 14% had low iron stores (ferritin <30 μg/L) and 3% had iron deficiency (ferritin <12 μg/L). The groups were balanced for baseline characteristics. Anemia prevalence increased during pregnancy and post-partum but was similar among intervention groups. In intention to treat analyses, prenatal ferritin was significantly higher among women receiving MM (geometric mean (μg/L) [95% CI]: 93.6 [89.3-98.2]) and IFA (91.9 [87.6-96.3]) compared to control (85.3 [81.5-89.2]). In per protocol analyses, women receiving MM or IFA had higher ferritin 3 months postpartum (MM 118.2 [109.3-127.8]), IFA 117.8 [108.7-127.7] vs control 101.5 [94.0-109.7]) and gave birth to infants with greater iron stores (MM 184.3 [176.1-192.9]), IFA 189.9 [181.6-198.3] vs control 175.1 [167.9-182.6]).ConclusionPreconception supplementation with MM or IFA resulted in modest increases in maternal and infant iron stores but did not impact anemia. Further research is needed to characterize the etiology of anemia in this population and identify effective interventions for reducing prenatal anemia.Trial registrationClinicalTrials.Gov NCT01665378.

Project description:BackgroundThymic size in early infancy predicts subsequent survival in low-income settings. The human thymus develops from early gestation, is most active in early life and is highly sensitive to malnutrition. Our objective was to test whether thymic size in infancy could be increased by maternal and/or infant nutritional supplementation.MethodsThe Early Nutrition and Immune Development (ENID) Trial was a randomized 2?×?2?×?2 factorial, partially blinded trial of nutritional supplementation conducted in rural Gambia, West Africa. Pregnant women (N?=?875) were randomized to four intervention groups (iron-folate (standard care), multiple micronutrients, protein energy or protein energy + multiple micronutrients at 'booking' (mean gestational age at enrolment?=?13.6?weeks, range 8-20?weeks) until delivery. The iron-folate and multiple micronutrient arms were administered in tablet form and the protein energy arms as a lipid-based nutritional supplement. All intervention arms contained 60?mg iron and 400??g folic acid per daily dose. From 24 to 52?weeks of age, infants from all groups were randomized to receive a daily lipid-based nutritional supplement, with or without additional micronutrients. Thymic size was assessed by ultrasonography at 1, 8, 24 and 52?weeks of infant age, and a volume-related thymic index calculated. Detailed data on infant growth, feeding status and morbidity were collected.ResultsA total of 724 (82.7%) mother-infant pairs completed the trial to infant age 52?weeks. Thymic size in infancy was not significantly associated with maternal supplement group at any post-natal time point. Infants who received the daily LNS with additional micronutrients had a significantly larger thymic index at 52?weeks of age (equivalent to an 8.0% increase in thymic index [95% CI 2.89, 13.4], P?=?0.002). No interaction was observed between maternal and infant supplement groups.ConclusionsA micronutrient-fortified lipid-based supplement given in the latter half of infancy increased thymic size, a key mediator of immune function. Improving the micronutrient status of infants from populations with marginal micronutrient status may improve immune development and survival.Trial registrationISRCTN registry (controlled-trials.com) Identifier: ISRCTN49285450.

Dataset Information

Iron Supplementation in Pregnancy or Infancy and Motor Development: A Randomized Controlled Trial.

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Iron Supplementation in Pregnancy or Infancy and Motor Development: A Randomized Controlled Trial.

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