Iron Absorption From Infant Formula and Iron Drops in Inf... | NCT01216709

Studies
Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)

NCT01216709

Sponsor

Umeå University

Status

Completed

Last Update Posted

Mar 26, 2020Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Infant
Dietary Supplements
Food, Fortified

Interventions

ferrous sulfate
iron-fortified infant formula (12.4 mg iron/L)
iron-fortified infant formula (2.3 mg iron/L)

Countries

Sweden

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

Mar 2020

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

Oct 2010Actual

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

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

Mar 25, 2020

Last Update Posted Date

Mar 26, 2020Actual

Name	Class
Swiss Federal Institute of Technology	OTHER
University of California, Davis	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
iron drops	Experimental	Dietary Supplement: ferrous sulfate
iron-fortified formula (2.3 mg iron/L)	Experimental	Other: iron-fortified infant formula (2.3 mg iron/L)
iron-fortified formula (12.4 mg iron /L)	Experimental	Other: iron-fortified infant formula (12.4 mg iron/L)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ferrous sulfate	Dietary Supplement	6.3 mg iron from iron drops and 0.3 mg iron from infant formula with no added iron (0.5 mg iron/L) for 45 days	iron drops

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iron absorption		1 month after enrollment

Secondary Outcomes

Measure	Description	Time Frame
indicators of iron metabolism, growth, and oxidative stress		1 month and 1.5 months after enrollment
zinc absorption		1 month after enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6-7 months of age at the start of intervention
healthy at enrollment
full-term (>37 gestational weeks at birth)
birth weight >2500 g
predominantly bottle-fed at recruitment

Exclusion Criteria:

iron deficiency at enrollment
previous or current use of iron supplements

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

7 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Magnus Domellöf, MD, PhD	Umeå University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Sciences, Pediatrics, Umeå University Hospital		Umeå		901 85	Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C020748	ferrous sulfate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided