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Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants

NCT00642863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1614

Last updated 2014-10-29

No results posted yet for this study

Summary

It is common in many populations that babies develop iron deficiency or iron deficiency anemia (that is, too few healthy red blood cells due to lack of iron). This is due to rapid growth in infancy combined with limited sources of iron in the infant diet. The amount of iron the baby receives across the placenta during pregnancy is another important factor. This study focuses on infants who are born with less than the usual amount of iron in their bodies. The purposes of the study are to assess effects of lower iron at birth on infant behavior and development and to determine if providing iron supplements to such infants beginning at 6 weeks fosters healthier development. Another part of the study will determine the effects of iron deficiency anemia at different times during infant development.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ferrous Sulfate (liquid) + vitamins A and D

a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.) and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.

DIETARY_SUPPLEMENT

vitamins A and D

a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.

DIETARY_SUPPLEMENT

Ferrous sulfate (liquid)

Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Betsy Lozoff, MD · University of Michigan

  • Jie Shao, MD · Children's Hospital, Zhejiang University School of Medicine

  • Zhengyan Zhao, MD · Children's Hospital, Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642863 on ClinicalTrials.gov