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

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

Study Overview

• Status: Terminated
• Conditions: Measurement of Docosahexaenoic Acid Levels in Pre-school Children
• Intervention / Treatment: Other: Milk-based beverage with DHA at mid level; Other: Milk-based beverage with DHA at high level; Other: Milk-based beverage without DHA

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Universty of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milk-based beverage with DHA at mid-level	Other: Milk-based beverage with DHA at mid level
Experimental: Milk-based beverage with DHA at high level	Other: Milk-based beverage with DHA at high level
Active Comparator: Milk-based beverage without DHA	Other: Milk-based beverage without DHA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure	6 months
Parental Product Assessment Questionnaire completed at Study Visit 2	once
Fatty Acid Desaturase (FADS) genotypes	Once
Plasma Vitamin D levels	6 months
Iron levels in the blood	6 months
Heart Rate	6 months
Height and Weight	6 months
Recall of dietary intake at each study visit	6 months
Medically-confirmed adverse events collected throughout the study period	6 months

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: University of Kansas; John Colombo, PhD, The University of Kansas
• Investigators: Study Director: Carol Lynn Berseth, M.D., Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 6022 (NYSPI IRB)