NCT01444261

Brief Summary

With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2010

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

September 28, 2011

Last Update Submit

March 29, 2017

Conditions

Iron DeficiencyAnemia

Keywords

iron deficiencyanemia

Outcome Measures

Primary Outcomes (1)

  • Iron deficiency anemia will be prevented in all infants before 5.5 mo of age

    Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.

    5.5 mo

Secondary Outcomes (1)

  • Determine the number of infants with iron deficiency between 5.5 and 9 mo of age

    9 mo

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Fer-in-Sol drops and iron-fortified cereal

Dietary Supplement: Fer-in-Sol

Control

OTHER

No intervention

Other: control

Interventions

Fer-in-SolDIETARY_SUPPLEMENT

Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal

Intervention
controlOTHER

No dietary supplements

Control

Eligibility Criteria

Age4 Weeks - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Term infants
  • gestational age 37-42 weeks
  • birth weight \> 2500 g
  • exclusively breastfed at 28 d of age
  • intend to breast feed until 9 mo of age

You may not qualify if:

  • supplemental formula before 4 mo of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Iron DeficienciesAnemia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ekhard Ziegler, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

December 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

US(1)