The Anemia Control Program: High or Low Iron Supplementation

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01166451
First received: July 19, 2010
Last updated: October 17, 2011
Last verified: October 2011

July 19, 2010
October 17, 2011
September 1991
August 1994   (final data collection date for primary outcome measure)
Iron deficiency anemia [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01166451 on ClinicalTrials.gov Archive Site
Longitudinal child behavior and development [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Anemia Control Program: High or Low Iron Supplementation
Iron Deficiency Anemia and Infant Behavior: Preventive Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Iron Deficiency Anemia
  • Cognitive Development
  • Motor Development
  • Dietary Supplement: Low-iron formula
    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.)
  • Dietary Supplement: High-iron formula
    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.)
  • Experimental: Low-iron
    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.
    Intervention: Dietary Supplement: Low-iron formula
  • Experimental: High-iron
    Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age.
    Intervention: Dietary Supplement: High-iron formula

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
835
March 2004
August 1994   (final data collection date for primary outcome measure)

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
Both
6 Months to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT01166451
R01 HD33487
Not Provided
Betsy Lozoff, MD, Professor of Pediatrics and Communicable Diseases and Research Professor, Center for Human Growth and Development, University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Betsy Lozoff, MD University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP