Healthy Infant Development Project

This study is currently recruiting participants.
Verified March 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00613717
First received: February 11, 2008
Last updated: March 19, 2014
Last verified: March 2014

February 11, 2008
March 19, 2014
November 2009
June 2014   (final data collection date for primary outcome measure)
Infant behavior and development [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
Infant behavior and development [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00613717 on ClinicalTrials.gov Archive Site
Infant anemia [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
Infant anemia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Healthy Infant Development Project
Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Iron Deficiency Anemia
  • Iron Deficiency
  • 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.

  • 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.

  • 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.

  • 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.

  • Experimental: a
    pre- and early postnatal iron
    Intervention: Dietary Supplement: folic acid + iron prenatally, vits A & D + iron postnatally
  • Experimental: b
    iron prenatal only
    Intervention: Dietary Supplement: folic acid + iron prenatally, vitamins A & D postnatally
  • Experimental: c
    iron early postnatal only
    Intervention: Dietary Supplement: folic acid prenatally, vitamins A & D + iron postnatally
  • Active Comparator: d
    no iron pre- or postnatal
    Intervention: Dietary Supplement: folic acid prenatally, vitamins A & D postnatally
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2400
January 2016
June 2014   (final data collection date for primary outcome measure)

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.
Both
up to 5 Days
No
Contact: Betsy Lozoff, MD 7347642443 blozoff@umich.edu
China
 
NCT00613717
1R01HD052069-01A2, 1R01HD052069-01A2
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Centers for Disease Control and Prevention
Principal Investigator: Betsy Lozoff, MD University of Michigan
Study Director: Li Ming, MD Peking University First Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP