NCT00841061

Brief Summary

The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
Last Updated

February 11, 2009

Status Verified

January 1, 2009

Enrollment Period

2.8 years

First QC Date

February 9, 2009

Last Update Submit

February 9, 2009

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • plasma ferritin

    280 days

Secondary Outcomes (1)

  • hemoglobin

    280

Study Arms (2)

Cereal L

ACTIVE COMPARATOR

Rice cereal with electrolytic iron

Dietary Supplement: electrolytic iron

Cereal M

ACTIVE COMPARATOR

Rice cereal with ferrous fumarate

Dietary Supplement: ferrous fumarate

Interventions

electrolytic ironDIETARY_SUPPLEMENT

1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age

Cereal L
ferrous fumarateDIETARY_SUPPLEMENT

1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age

Cereal M

Eligibility Criteria

Age28 Days - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • exclusively breastfed
  • birth weight between 2500 and 4200g
  • gestational age \>36 weeks

You may not qualify if:

  • supplementing formula
  • no iron drops

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22.

    PMID: 21178077DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous fumarate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ekhard E Ziegler, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 11, 2009

Study Start

July 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 11, 2009

Record last verified: 2009-01

Locations

US(1)