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The Anemia Control Program: High or Low Iron Supplementation

NCT01166451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 835

Last updated 2011-10-18

No results posted yet for this study

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.

Conditions

Interventions

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.)

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Betsy Lozoff, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-09-30
Primary Completion
1994-08-31
Completion
2004-03-31

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166451 on ClinicalTrials.gov