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

NCT00642863 | Completed DMC

• 1 other identifier: 2P01HD039386-06A1
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 1

Brief 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

Iron Deficiency; Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Infant behavior and development

  6 weeks; 9 and 18 months

Secondary Outcomes (2)

• Low or marginal birth iron

  6 weeks

• Infant anemia

  9 and 18 months

Study Arms (7)

Low birth iron

EXPERIMENTAL

Infants with low birth iron who receive vitamins A and D + iron

Dietary Supplement: Ferrous Sulfate (liquid) + vitamins A and D

Marginal birth iron 1

EXPERIMENTAL

Infants with marginal birth iron randomized to receive vitamins A and D + iron

Dietary Supplement: Ferrous Sulfate (liquid) + vitamins A and D

Marginal birth iron 2

ACTIVE COMPARATOR

Infants with marginal birth iron randomized to receive vitamins A and D without iron

Dietary Supplement: vitamins A and D

Normal birth iron

ACTIVE COMPARATOR

Infants with normal birth iron who receive vitamins A and D without iron

Dietary Supplement: vitamins A and D

Combined ID

EXPERIMENTAL

Marginal-birth-iron vitamins only-treated infants who have IDA at 9 mo.

Dietary Supplement: Ferrous sulfate (liquid)

Early postnatal IDA

EXPERIMENTAL

Infants with IDA at 9 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks

Dietary Supplement: Ferrous sulfate (liquid)

Late postnatal IDA

EXPERIMENTAL

Infants with IDA at 18 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks. These infants were also not anemic when screened at 9 months.

Dietary Supplement: Ferrous sulfate (liquid)

Interventions

Ferrous Sulfate (liquid) + vitamins A and D DIETARY_SUPPLEMENT

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.

Low birth iron; Marginal birth iron 1

vitamins A and D DIETARY_SUPPLEMENT

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

Marginal birth iron 2; Normal birth iron

Ferrous sulfate (liquid) DIETARY_SUPPLEMENT

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.

Combined ID; Early postnatal IDA; Late postnatal IDA

Eligibility Criteria

• Age: Up to 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants born at Maternity and Children's Hospitals of Fuyang city in China
• healthy term newborns from uncomplicated pregnancies for hematology screening
• healthy full-term singleton infants with cord Hb and ferritin in the low-marginal or normal range for developmental testing

You may not qualify if:

• perinatal complications

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• 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.

  PMID: 27836288 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency; Behavior

Interventions

ferrous sulfate; Fluid Therapy; Fumigant 93

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Betsy Lozoff, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Jie Shao, MD

  Children's Hospital, Zhejiang University School of Medicine

  STUDY DIRECTOR

• Zhengyan Zhao, MD

  Children's Hospital, Zhejiang University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 25, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2014-03

Locations

CN (1)