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

Not Applicable

Terminated

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

• Registration Number: NCT01897948
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk-based beverage with DHA at mid-level	Milk-based beverage with DHA at mid level	-
Milk-based beverage with DHA at high level	Milk-based beverage with DHA at high level	-
Milk-based beverage without DHA	Milk-based beverage without DHA	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Universty of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States