Rosa M Angulo-Barroso1, Ming Li2, Denise C C Santos3, Yang Bian2, Julie Sturza4, Yaping Jiang5, Niko Kaciroti4, Blair Richards4, Betsy Lozoff6. 1. Department of Kinesiology, California State University, Northridge, Northridge, California; Center for Human Growth and Development, and rosa.angulobarroso@csun.edu. 2. Department of Pediatrics, and. 3. Center for Human Growth and Development, and Human Movement Sciences Graduate Program, Methodist University of Piracicaba, Piracicaba, SP, Brazil. 4. Center for Human Growth and Development, and. 5. Clinical Laboratory, Peking University First Hospital, Beijing, China; and. 6. Center for Human Growth and Development, and Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, Michigan;
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/placeboin 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.
RCT Entities:
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.
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