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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Measurement of Docosahexaenoic Acid Levels in Pre-school Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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Milk-based beverage with DHA at mid-level

Group Type EXPERIMENTAL

Milk-based beverage with DHA at mid level

Intervention Type OTHER

Milk-based beverage with DHA at high level

Group Type EXPERIMENTAL

Milk-based beverage with DHA at high level

Intervention Type OTHER

Milk-based beverage without DHA

Group Type ACTIVE_COMPARATOR

Milk-based beverage without DHA

Intervention Type OTHER

Interventions

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Milk-based beverage without DHA

Intervention Type OTHER

Milk-based beverage with DHA at mid level

Intervention Type OTHER

Milk-based beverage with DHA at high level

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes