NCT01166451

The Anemia Control Program: High or Low Iron Supplementation

Iron Deficiency Anemia and Infant Behavior: Preventive Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 835 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 6 Months – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency Anemia
• Cognitive Development
• Motor Development

Interventions

Type	Name	Description
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.)
DIETARY_SUPPLEMENT	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.)

Timeline

• Start date: 1991-09-01
• Primary completion: 1994-08-01
• Completion: 2004-03-01
• First posted: 2010-07-21
• Last updated: 2011-10-18

Locations

1 site across 1 country: Chile