The Anemia Control Program: High or Low Iron Supplementation
NCT ID: NCT01166451
Last Updated: 2011-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
835 participants
INTERVENTIONAL
1991-09-30
2004-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low-iron
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
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
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
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.)
Interventions
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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.)
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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* another infant \<12 months in household
* infant in daycare
* unstable, illiterate, or psychotic caregiver
6 Months
6 Months
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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University of Michigan
Principal Investigators
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Betsy Lozoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Instituto de Nutriticion y Tecnologia de los Alimentos
Santiago, , Chile
Countries
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References
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Walter T, Pino P, Pizarro F, Lozoff B. Prevention of iron-deficiency anemia: comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pediatr. 1998 Apr;132(4):635-40. doi: 10.1016/s0022-3476(98)70352-x.
East PL, Reid B, Blanco E, Burrows R, Lozoff B, Gahagan S. Iron supplementation given to nonanemic infants: neurocognitive functioning at 16 years. Nutr Neurosci. 2023 Jan;26(1):40-49. doi: 10.1080/1028415X.2021.2013399. Epub 2021 Dec 19.
East P, Doom J, Blanco E, Burrows R, Lozoff B, Gahagan S. Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy. Nutr Neurosci. 2022 Apr;25(4):709-718. doi: 10.1080/1028415X.2020.1804099. Epub 2020 Aug 11.
Gahagan S, Delker E, Blanco E, Burrows R, Lozoff B. Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years. J Pediatr. 2019 Sep;212:124-130.e1. doi: 10.1016/j.jpeds.2019.05.030. Epub 2019 Jun 26.
Lozoff B, Castillo M, Clark KM, Smith JB. Iron-fortified vs low-iron infant formula: developmental outcome at 10 years. Arch Pediatr Adolesc Med. 2012 Mar;166(3):208-15. doi: 10.1001/archpediatrics.2011.197. Epub 2011 Nov 7.
Other Identifiers
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