NCT01897948

Terminated

The Effects of Feeding Different Levels of Docosahexaenoic A...

Mead Johnson Nutrition Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

6022

Study Type

interventional

Actual enrollment (reported)

18

Locations

1 country

Sites

1

Timeline

Study Start

July 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2014

Actual (reported)

Study Completion

March 2014

Actual (reported)

Brief Summary

This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 18 participants
Study completion date: March 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 3, 2013
Actual (reported)
First Posted
July 12, 2013
Actual (reported)
Primary Completion
March 2014
Actual (reported)
Study Completion
March 2014
Actual (reported)

Last Updated: April 7, 2014
Status Verified: April 2014
Last Update Submitted: April 4, 2014

Conditions

Measurement of Docosahexaenoic Acid Levels in Pre-school Children

Outcome Measures

Primary Outcomes (2)

Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid
6 months
Cognitive Measures - Executive Function, Language Development, and Behavior Assessment
6 months

Secondary Outcomes (9)

Fatty Acid Desaturase (FADS) genotypes
Once
Plasma Vitamin D levels
6 months
Iron levels in the blood
6 months
Blood Pressure
6 months
Heart Rate
6 months
+4 more secondary outcomes

Study Arms (3)

Milk-based beverage with DHA at mid-level

EXPERIMENTAL

Other: Milk-based beverage with DHA at mid level

Milk-based beverage with DHA at high level

EXPERIMENTAL

Other: Milk-based beverage with DHA at high level

Milk-based beverage without DHA

ACTIVE COMPARATOR

Other: Milk-based beverage without DHA

Interventions

Milk-based beverage without DHAOther

Milk-based beverage without DHA

Milk-based beverage with DHA at mid levelOther

Milk-based beverage with DHA at mid-level

Eligibility Criteria

Age3 Years - 3 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Child is 3 years of age ± 90 days
Weight for length is within 10th to 90th percentile as plotted on WHO growth charts

Sponsors & Collaborators

John Colombo, PhD, The University of Kansas
Type not reportedcollaborator
Mead Johnson Nutrition
Industrylead
University of Kansas

Study Sites (1)

Universty of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Study Officials

Carol Lynn Berseth, M.D.
Mead Johnson Nutrition
STUDY DIRECTOR

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 12, 2013

Study Start

July 2013

Date type not reported

This date has not been verified as actual or estimated.

Milk-based beverage with DHA at high levelOther

Milk-based beverage with DHA at high level

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis

Parent is willing to exclude sources of DHA from child's diet during the study

Parent agrees not to give vitamins to child during the study

English is the primary language in the home

Signed Informed Consent and Protected Health Information

You may not qualify if:

Gestational age at birth ≤ 36 weeks
History of neuro/psychiatric conditions
History of underlying metabolic or chronic disease
Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
History of suspected or known cow milk protein intolerance
Child's diet contains sources of supplemental DHA more than one time per week
Child is from a multiple birth and the sibling(s) are living in the same household
Child is enrolled in another interventional clinical research study
Use of antihistamines within 12 hours of cognitive testing

Contact the study team to confirm eligibility.

Othercollaborator

Primary Completion

March 2014

Actual (reported)

Study Completion

March 2014

Actual (reported)

Last Updated

April 7, 2014

Record last verified: 2014-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01897948
Data provider: ClinicalTrials.gov
Source updated: 2014-04-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:22 UTC

Locations

US(1)

Study Stopped

The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (3)

Milk-based beverage with DHA at mid-level

Milk-based beverage with DHA at high level

Milk-based beverage without DHA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (3)

Milk-based beverage with DHA at mid-level

Milk-based beverage with DHA at high level

Milk-based beverage without DHA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations