An interventional study of Low-iron formula and High-iron formula in Iron Deficiency Anemia, Cognitive Development and Motor Development, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in Chile. Open to participants aged 6 Months to 6 Months. Per ClinicalTrials.gov, last updated 2011-10-18.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Prevention
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.
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.
660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.
This study's enrollment of 835 is above the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 25 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
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Exclusion Criteria:
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
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
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.)
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.)
Iron deficiency anemia
Time frame: 12 and 18 months
Longitudinal child behavior and development
Time frame: 10 years
The record gives a start of Sep 1991, a primary completion of Aug 1994 and a completion of Mar 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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