Healthy Infant Development Project

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Infant behavior and development [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant anemia [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: November 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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).

  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613717

Contacts
Contact: Betsy Lozoff, MD 7347642443 blozoff@umich.edu

Locations
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Li Ming, MD    010-6655-1122      
Sponsors and Collaborators
Investigators
Principal Investigator: Betsy Lozoff, MD University of Michigan
Study Director: Li Ming, MD Peking University First Hospital
  More Information

No publications provided

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, 1R01HD052069-01A2
Study First Received: February 11, 2008
Last Updated: March 19, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014