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Completed

NCT Number: NCT01166451

The Anemia Control Program: High or Low Iron Supplementation

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Cognitive Development Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Motor Development Nutritional and Metabolic Diseases

Age range

6 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Nutriticion y Tecnologia de los Alimentos

Santiago, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-iron formula

Dietary Supplement

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

Dietary Supplement

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.)

Primary outcomes

  1. Iron deficiency anemia

    Time frame: 12 and 18 months

Secondary outcomes

  1. Longitudinal child behavior and development

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Iron Deficiency Anemia and Infant Behavior: Preventive Trial

Important dates

Study start
1991
Primary completion
1994
Study completion
2004
First posted
Jul 21, 2010
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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