Iron and the Breast-Fed Infant: Iron Status and Two Regim... | NCT00760890

Studies
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

NCT00760890

Sponsor

National Institutes of Health (NIH)

Status

Completed

Last Update Posted

Sep 26, 2008Estimated

Enrollment

171Actual

Phase

Not Applicable

Conditions

Iron Deficiency

Interventions

Fer-In-Sol (ferrous sulfate)
Iron fortified cereal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2001

Primary Completion Date

Jun 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2008

Last Update Posted Date

Sep 26, 2008Estimated

Description Module

Brief Summary

Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

171Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Medicinal Iron	Dietary Supplement: Fer-In-Sol (ferrous sulfate)
B	Experimental	Iron fortified wet pack cereal	Dietary Supplement: Iron fortified cereal
C	No Intervention	Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fer-In-Sol (ferrous sulfate)	Dietary Supplement	7.5 mg/day in the form of 0.3 ml once each day	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Iron status		3 times during the intervention

Secondary Outcomes

Measure	Description	Time Frame
Growth		At the end of intervention
Tolerance (gastrointestinal)		During intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Predominantly breastfed (at 4 months) term infants

Exclusion Criteria:

Not predominantly breastfed at 4 months
Premature infants

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

24 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ekhard E Ziegler, M.D.	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fomon Infant Nutrition Unit		Iowa City	Iowa	52242	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19458014	Derived	Ziegler EE, Nelson SE, Jeter JM. Iron status of breastfed infants is improved equally by medicinal iron and iron-fortified cereal. Am J Clin Nutr. 2009 Jul;90(1):76-87. doi: 10.3945/ajcn.2008.27350. Epub 2009 May 20.

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases