Status:
COMPLETED
Effect of Long-Chain Polyunsaturated Fatty Acid Supplementation on Toddler Cognition
Lead Sponsor:
Retina Foundation of the Southwest
Collaborating Sponsors:
DSM Nutritional Products, Inc.
Conditions:
Infant Development
Eligibility:
All Genders
351-379 years
Phase:
NA
Brief Summary
The hypothesis to be examined is that dietary LCP-supplementation in the second and third years of life will improve cognitive and visual maturation in early childhood.
Detailed Description
A total number of 114 toddlers at 12 months ± 2 weeks of age will be recruited and randomized to two groups (placebo or LCP-supplemented). Cognition, visual function, anthropometric, immunologic and b...
Eligibility Criteria
Inclusion
- Toddlers (12 months ± 2 weeks of age at randomization).
- Breast-fed or formula-fed during the first 12 months of life.
- Mother plans to discontinue breast-feeding/formula feeding by 13 months of age.
- Full-term at birth (37-42 weeks post-conception).
- English as the primary language in the home.
Exclusion
- History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development of the participant or the evaluation of the participant.
- Toddler weighing \<5% or \>95% of the normative values in Centers for Disease Control and Prevention (CDC) growth charts released in 2000 (www.cdc.gov/growthcharts/).
- Evidence of poor food intake at time of randomization.
- Parent(s) currently supplement or plan to supplement child with \>100 mg DHA per day (fish, fish oil, capsules or chewables).
Key Trial Info
Start Date :
January 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2016
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00982462
Start Date
January 20 2011
End Date
June 29 2016
Last Update
April 25 2017
Active Locations (1)
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1
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231