Evaluation of Mineral Absorption in Infants Fed Infant Fo... | NCT01177917

Studies
Evaluation of Mineral Absorption in Infants Fed Infant Formula

NCT01177917

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

Aug 9, 2010Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Mineral Absorption in the Urine

Interventions

Infant Formula

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

Aug 2010

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

Aug 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Aug 6, 2010

First Submission Date that Met QC Criteria

Aug 6, 2010

First Posted Date

Aug 9, 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

Aug 6, 2010

Last Update Posted Date

Aug 9, 2010Estimated

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

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cow milk-based infant formula with prebiotic blend	Experimental		Other: Infant Formula
Marketed Cow milk-based infant formula	Placebo Comparator		Other: Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infant Formula	Other		Cow milk-based infant formula with prebiotic blend Marketed Cow milk-based infant formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the amount of minerals in the urine

Secondary Outcomes

Measure	Description	Time Frame
Compare the amount of vitamins and minerals in the blood

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton
Term infant
Birth weight of 2500 g or more
56-70 days of age
Signed informed consent
Consuming a cow's milk-based infant formula for at least 24 hours.

Exclusion Criteria:

History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
Use of multiple vitamin and mineral supplements prior to enrollment.
Evidence of formula intolerance or poor intake at time of randomization

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

56 Days

Maximum Age

70 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Iowa		Coralville	Iowa	52241	United States
Pediatric Clinical Trials Unit

Intervention Browse Module

MeSH Terms

ID	Term
D041943	Infant Formula

Ancestor Terms

ID	Term
D041941	Milk Substitutes
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided