NCT01166451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1991

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1991

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1994

Completed
9.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

2.9 years

First QC Date

July 19, 2010

Last Update Submit

October 17, 2011

Conditions

Iron Deficiency AnemiaCognitive DevelopmentMotor Development

Keywords

iron deficiency anemiacognitive developmentmotor development

Outcome Measures

Primary Outcomes (1)

  • Iron deficiency anemia

    12 and 18 months

Secondary Outcomes (1)

  • Longitudinal child behavior and development

    10 years

Study Arms (2)

Low-iron

EXPERIMENTAL

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.

Dietary Supplement: Low-iron formula

High-iron

EXPERIMENTAL

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

Dietary Supplement: High-iron formula

Interventions

Low-iron formulaDIETARY_SUPPLEMENT

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.)

Low-iron
High-iron formulaDIETARY_SUPPLEMENT

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.)

High-iron

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Nutriticion y Tecnologia de los Alimentos

Santiago, Chile

Location

Related Publications (5)

  • 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.

    PMID: 9580762RESULT

  • 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.

    PMID: 34927561DERIVED

  • 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.

    PMID: 32778008DERIVED

  • 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.

    PMID: 31253407DERIVED

  • 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.

    PMID: 22064877DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Betsy Lozoff, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 21, 2010

Study Start

September 1, 1991

Primary Completion

August 1, 1994

Study Completion

March 1, 2004

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

CL(1)