Healthy Infant Development Project

Study Description

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Brief Summary:

The Healthy Infant Development Project will determine if providing micronutrient supplements to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and development in babies.

Condition or disease	Intervention/treatment	Phase
Iron Deficiency Anemia; Iron Deficiency	Dietary Supplement: folic acid + iron prenatally, vits A & D + iron postnatally; Dietary Supplement: folic acid + iron prenatally, vitamins A & D postnatally; Dietary Supplement: folic acid prenatally, vitamins A & D + iron postnatally; Dietary Supplement: folic acid prenatally, vitamins A & D postnatally	Not Applicable

Detailed Description:

Iron deficiency (ID) is the most common single nutrient disorder in the world, and pregnant women and infants are at highest risk. With long-lasting differences in prior studies, effects on the developing brain and infant behavior and development are among the most worrisome concerns. The proposed study will determine developmental/ behavioral effects of preventing ID depending on timing (Aim 1) and duration (Aim 2) of iron supplementation (i.e., pre- and/or early postnatally). The study will relate outcomes to severity of ID (Aim 3) and consider reversibility of effects with iron therapy, depending on timing (Aim 4). We expect different neurobehavioral effects when ID occurs or is prevented/treated during different phases of brain development (proliferation and growth phase primarily prenatally and regional diversification and interconnection largely in infancy). The project entails 2 randomized controlled trials (RCTs) to support causal inferences about preventing ID pre- and/or early postnatally. The project builds on a large US CDC-supported study (Pregnancy Nutrition Study) involving pregnant women in rural China (ClinicalTrials.gov identifier: NCT00133744). Study groups of infants in the proposed RCTs combined are a) pre- and early postnatal iron, b) prenatal iron, c) early postnatal iron, and d) neither (n = 500/group, total 2000, at study end). Iron status and sensitive sensory, motor, cognitive, language, and social-emotional outcomes will be assessed at birth, 9 and 18 mo. Results of Aims 1 & 2 will determine the best window to prevent ID effects and whether breast-fed infants benefit from iron before 6 mo. Aim 3 (severity) will determine the level of ID at which different developmental domains are adversely affected. If ill effects of ID without anemia are documented, there could be major policy implications; screening is currently only for anemia. Detecting more or less vulnerable domains may also point to other interventions in addition to iron therapy. To identify reversibile effects, depending on age of treatment (Aim 4), outcomes at 18 mo will be compared for infants 1) never iron-deficient, 2) poor iron status at birth and assigned to postnatal iron, 3) maternal IDA (anemia) treated in the 1st or 2nd trimester, 4) infant IDA treated at 9 mo, and 5) IDA treated at 18 mo. The results will be highly relevant to global practice and policy regarding ID, which differentially affects poor and/or minority women and infants everywhere.

The project is expected to continue with a 5-year follow-up (Nov 2014- Oct 2019).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2371 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts
Study Start Date :	November 2009
Actual Primary Completion Date :	June 2014
Actual Study Completion Date :	June 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: a; pre- and early postnatal iron	Dietary Supplement: folic acid + iron prenatally, vits A & D + iron postnatally; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D.
Experimental: b; iron prenatal only	Dietary Supplement: folic acid + iron prenatally, vitamins A & D postnatally; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.
Experimental: c; iron early postnatal only	Dietary Supplement: folic acid prenatally, vitamins A & D + iron postnatally; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D.
Active Comparator: d; no iron pre- or postnatal	Dietary Supplement: folic acid prenatally, vitamins A & D postnatally; Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.

Outcome Measures

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Primary Outcome Measures :

1. Infant behavior and development [ Time Frame: 9 and 18 months ]

Secondary Outcome Measures :

1. Infant anemia [ Time Frame: 9 and 18 months ]

Eligibility Criteria

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Ages Eligible for Study:	up to 5 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- Full-term healthy neonates born to study mothers from CDC's Prenatal Nutrition Study with randomly selected lot numbers.

Exclusion Criteria:

• birth weight < 2500 g
• gestational age ≤ 37 wk
• major perinatal complications
• major congenital anomaly
• multiple birth.

Contacts and Locations

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Locations

China
Peking University First Hospital
Beijing, China, 100034

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Centers for Disease Control and Prevention

Investigators

Principal Investigator:	Betsy Lozoff, MD	University of Michigan
Study Director:	Li Ming, MD	Peking University First Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Clark KM, Li M, Zhu B, Liang F, Shao J, Zhang Y, Ji C, Zhao Z, Kaciroti N, Lozoff B. Breastfeeding, Mixed, or Formula Feeding at 9 Months of Age and the Prevalence of Iron Deficiency and Iron Deficiency Anemia in Two Cohorts of Infants in China. J Pediatr. 2017 Feb;181:56-61. doi: 10.1016/j.jpeds.2016.10.041. Epub 2016 Nov 8.

Lozoff B, Jiang Y, Li X, Zhou M, Richards B, Xu G, Clark KM, Liang F, Kaciroti N, Zhao G, Santos DC, Zhang Z, Tardif T, Li M. Low-Dose Iron Supplementation in Infancy Modestly Increases Infant Iron Status at 9 Mo without Decreasing Growth or Increasing Illness in a Randomized Clinical Trial in Rural China. J Nutr. 2016 Mar;146(3):612-21. doi: 10.3945/jn.115.223917. Epub 2016 Jan 20.

Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00613717 History of Changes
Other Study ID Numbers:	1R01HD052069-01A2 ( U.S. NIH Grant/Contract )
First Posted:	February 13, 2008
Last Update Posted:	October 29, 2014
Last Verified:	March 2014

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

iron deficiency anemia; iron deficiency; infant; development; behavior

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Vitamins; Folic Acid; Vitamin A; Vitamin D; Iron; Vitamin B Complex	Retinol palmitate; Micronutrients; Growth Substances; Physiological Effects of Drugs; Trace Elements; Hematinics; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Anticarcinogenic Agents; Antineoplastic Agents; Bone Density Conservation Agents