The Anemia Control Program: High or Low Iron Supplementation

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia; Cognitive Development; Motor Development
• Interventions: Dietary Supplement: Low-iron formula; Dietary Supplement: High-iron formula

• Registration Number: NCT01166451
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Timeline

• Study Start: 1991-09
• Primary Completion: 1994-08
• Study Completion: 2004-03
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-21
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-17
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 835

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-iron	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.
High-iron	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.

Primary Outcome Measures

Name	Time	Method
Iron deficiency anemia	12 and 18 months

Secondary Outcome Measures

Name	Time	Method
Longitudinal child behavior and development	10 years

Trial Locations

Locations (1)

Instituto de Nutriticion y Tecnologia de los Alimentos; 🇨🇱 Santiago, Chile