The Effects of Study Products Containing Varying Quantiti... | NCT01174134

Studies
The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)

NCT01174134

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

Sep 2, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Levels of DHA in the Blood

Interventions

Nutritional beverage

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 2011

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

Jul 2006

Primary Completion Date

May 2007Actual

Completion Date

Not provided

First Submitted Date

Jul 30, 2010

First Submission Date that Met QC Criteria

Aug 2, 2010

First Posted Date

Aug 3, 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 31, 2011

Last Update Posted Date

Sep 2, 2011Estimated

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	Intervention Names
Milk-based beverage w/out DHA	Placebo Comparator	Other: Nutritional beverage
Milk-based beverage with DHA	Experimental	Other: Nutritional beverage
Milk-based beverage containing DHA at a higher level	Experimental	Other: Nutritional beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional beverage	Other		Milk-based beverage containing DHA at a higher level Milk-based beverage w/out DHA Milk-based beverage with DHA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use

Secondary Outcomes

Measure	Description	Time Frame
Growth
Determination of nutrient status, including iron and vitamin D status
Adverse Events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is 18 to 36 months of age
Participant's current weight and height within the 10th to 90th percentiles
Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis
Participant lives at home with parent(s) or other family member(s)
Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)

Exclusion Criteria:

Participant who is receiving any breast milk at time of randomization
Participant with an active infection.
Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.
Known or suspected intolerance to cow's milk protein
Participant diagnosed with diabetes
Participant is from a multiple birth and the sibling(s) are still living
Participant with a sibling that has participated in this study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Carlson, Ph.D.	University of Kansas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas		Kansas City	Kansas	66160	United States