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

Mead Johnson Nutrition

Status: Terminated

Conditions: Measurement of Docosahexaenoic Acid Levels in Pre-school Children

Treatments: Other: Milk-based beverage with DHA at high level; Other: Milk-based beverage with DHA at mid level; Other: Milk-based beverage without DHA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01897948

6022 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 3 to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

18 participants in 3 patient groups

Milk-based beverage with DHA at mid-level

Experimental group

Treatment:

Other: Milk-based beverage with DHA at mid level

Milk-based beverage with DHA at high level

Experimental group

Treatment:

Other: Milk-based beverage with DHA at high level

Milk-based beverage without DHA

Active Comparator group

Treatment:

Other: Milk-based beverage without DHA