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
  Purpose

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.


Condition Intervention
Iron Deficiency Anemia
Cognitive Development
Motor Development
Dietary Supplement: Low-iron formula
Dietary Supplement: High-iron formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Iron Deficiency Anemia and Infant Behavior: Preventive Trial

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Iron deficiency anemia [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Longitudinal child behavior and development [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 835
Study Start Date: September 1991
Study Completion Date: March 2004
Primary Completion Date: August 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.)
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.
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.)

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.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166451

Locations
Chile
Instituto de Nutriticion y Tecnologia de los Alimentos
Santiago, Chile
Sponsors and Collaborators
Investigators
Principal Investigator: Betsy Lozoff, MD University of Michigan
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Betsy Lozoff, MD, Professor of Pediatrics and Communicable Diseases and Research Professor, Center for Human Growth and Development, University of Michigan
ClinicalTrials.gov Identifier: NCT01166451     History of Changes
Other Study ID Numbers: R01 HD33487
Study First Received: July 19, 2010
Last Updated: October 17, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
iron deficiency anemia
cognitive development
motor development

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014