The Anemia Control Program: High or Low Iron Supplementation

This study has been completed.

Sponsor:

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT01166451

First received: July 19, 2010

Last updated: October 17, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2010

Last Updated Date

October 17, 2011

Start Date ^ICMJE

September 1991

Primary Completion Date

August 1994 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Iron deficiency anemia [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01166451 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Longitudinal child behavior and development [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Anemia Control Program: High or Low Iron Supplementation

Official Title ^ICMJE

Iron Deficiency Anemia and Infant Behavior: Preventive Trial

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Iron Deficiency Anemia
Cognitive Development
Motor Development

Intervention ^ICMJE

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.)

Study Arm (s)

Experimental: 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.

Intervention: Dietary Supplement: Low-iron formula
Experimental: 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.

Intervention: Dietary Supplement: High-iron formula

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

835

Completion Date

March 2004

Primary Completion Date

August 1994 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 6 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Chile

Administrative Information

NCT Number ^ICMJE

NCT01166451

Other Study ID Numbers ^ICMJE

R01 HD33487

Has Data Monitoring Committee

Not Provided

Responsible Party

Betsy Lozoff, MD, Professor of Pediatrics and Communicable Diseases and Research Professor, Center for Human Growth and Development, University of Michigan

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Betsy Lozoff, MD

University of Michigan

Information Provided By

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

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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