The Anemia Control Program: High or Low Iron Supplementation

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Iron Deficiency Anemia; Cognitive Development; Motor Development

Treatments: Dietary Supplement: High-iron formula; Dietary Supplement: Low-iron formula

Study type: Interventional

Funder types: NIH

Identifiers

NCT01166451

R01HD033487

Details and patient eligibility

About

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.

Full 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.

Enrollment: 835 patients

Sex: All

Ages: 6 to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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835 participants in 2 patient groups

Low-iron

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Low-iron formula

High-iron

Experimental group

Description:

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

Treatment:

Dietary Supplement: High-iron formula