The Anemia Control Program: High or Low Iron Supplementation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Iron Deficiency Anemia and Infant Behavior: Preventive Trial

Conditions
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Iron Deficiency Anemia, Cognitive Development, Motor Development

Intervention / Treatment
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* Dietary Supplement: Low-iron formula
* Dietary Supplement: High-iron formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-iron<br>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<br>* 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.)<br>|
| Experimental: High-iron<br>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<br>* 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.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron deficiency anemia |  | 12 and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal child behavior and development |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency anemia, cognitive development, motor development