The Anemia Control Program: High or Low Iron Supplementation

Iron Deficiency Anemia Clinical Trial

Official title:

Iron Deficiency Anemia and Infant Behavior: Preventive Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166451
• Other study ID #: R01HD033487
• Status: Completed
• Phase: N/A
• First received: July 19, 2010
• Last updated: October 17, 2011
• Start date: September 1991
• Est. completion date: March 2004

Study information

• Verified date: October 2011
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: March 2004
• Est. primary completion date: August 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cognitive Development
• Deficiency Diseases
• Iron Deficiency Anemia
• Motor Development

Intervention

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.)
• 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.)

Locations

Country	Name	City	State
Chile	Instituto de Nutriticion y Tecnologia de los Alimentos	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron deficiency anemia		12 and 18 months	No
Secondary	Longitudinal child behavior and development		10 years	No