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The Anemia Control Program: High or Low Iron Supplementation

Primary Purpose

Iron Deficiency Anemia, Cognitive Development, Motor Development

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Low-iron formula
High-iron formula
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia, cognitive development, motor development

Eligibility Criteria

6 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birth weight >= 3.0 kg
  • single birth
  • no major congenital anomalies
  • no major birth or neonatal complications
  • no emergency c-section
  • no jaundice requiring phototherapy
  • no hospitalization for more than 5 days
  • no chronic illness
  • no iron therapy
  • already started to received some bottle feedings by 6 months of age

Exclusion Criteria:

  • residence outside identified neighborhoods
  • another infant <12 months in household
  • infant in daycare
  • unstable, illiterate, or psychotic caregiver

Sites / Locations

  • Instituto de Nutriticion y Tecnologia de los Alimentos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-iron

High-iron

Arm Description

Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age.

Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age.

Outcomes

Primary Outcome Measures

Iron deficiency anemia

Secondary Outcome Measures

Longitudinal child behavior and development

Full Information

First Posted
July 19, 2010
Last Updated
October 17, 2011
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01166451
Brief Title
The Anemia Control Program: High or Low Iron Supplementation
Official Title
Iron Deficiency Anemia and Infant Behavior: Preventive Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 1991 (undefined)
Primary Completion Date
August 1994 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron status in infancy and on development longitudinally.
Detailed Description
For a detailed description of the clinical trial setting and procedures in infancy, please refer to the following: Walter T, Pino P, Pizarro F and Lozoff B. Prevention of iron-deficiency anemia: Comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pedr 1998:132:635-40.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Cognitive Development, Motor Development
Keywords
iron deficiency anemia, cognitive development, motor development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
835 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-iron
Arm Type
Experimental
Arm Description
Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age.
Arm Title
High-iron
Arm Type
Experimental
Arm Description
Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-iron formula
Intervention Description
Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age. Low-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
Intervention Type
Dietary Supplement
Intervention Name(s)
High-iron formula
Intervention Description
Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age. High-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
Primary Outcome Measure Information:
Title
Iron deficiency anemia
Time Frame
12 and 18 months
Secondary Outcome Measure Information:
Title
Longitudinal child behavior and development
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birth weight >= 3.0 kg single birth no major congenital anomalies no major birth or neonatal complications no emergency c-section no jaundice requiring phototherapy no hospitalization for more than 5 days no chronic illness no iron therapy already started to received some bottle feedings by 6 months of age Exclusion Criteria: residence outside identified neighborhoods another infant <12 months in household infant in daycare unstable, illiterate, or psychotic caregiver
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betsy Lozoff, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Nutriticion y Tecnologia de los Alimentos
City
Santiago
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
9580762
Citation
Walter T, Pino P, Pizarro F, Lozoff B. Prevention of iron-deficiency anemia: comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pediatr. 1998 Apr;132(4):635-40. doi: 10.1016/s0022-3476(98)70352-x.
Results Reference
result
PubMed Identifier
34927561
Citation
East PL, Reid B, Blanco E, Burrows R, Lozoff B, Gahagan S. Iron supplementation given to nonanemic infants: neurocognitive functioning at 16 years. Nutr Neurosci. 2023 Jan;26(1):40-49. doi: 10.1080/1028415X.2021.2013399. Epub 2021 Dec 19.
Results Reference
derived
PubMed Identifier
32778008
Citation
East P, Doom J, Blanco E, Burrows R, Lozoff B, Gahagan S. Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy. Nutr Neurosci. 2022 Apr;25(4):709-718. doi: 10.1080/1028415X.2020.1804099. Epub 2020 Aug 11.
Results Reference
derived
PubMed Identifier
31253407
Citation
Gahagan S, Delker E, Blanco E, Burrows R, Lozoff B. Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years. J Pediatr. 2019 Sep;212:124-130.e1. doi: 10.1016/j.jpeds.2019.05.030. Epub 2019 Jun 26.
Results Reference
derived
PubMed Identifier
22064877
Citation
Lozoff B, Castillo M, Clark KM, Smith JB. Iron-fortified vs low-iron infant formula: developmental outcome at 10 years. Arch Pediatr Adolesc Med. 2012 Mar;166(3):208-15. doi: 10.1001/archpediatrics.2011.197. Epub 2011 Nov 7.
Results Reference
derived

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The Anemia Control Program: High or Low Iron Supplementation

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