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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT00982462 |
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Date of registration:
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21/09/2009 |
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Primary sponsor: |
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Public title:
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Effect of Long-Chain Polyunsaturated Fatty Acid Supplementation on Toddler Cognition
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Scientific title:
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The Effects of Extended Duration of Long-Chain Polyunsaturated Fatty Acid (LCP)-Supplementation on Neurological and Immunological Development in Toddlers |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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114 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00982462 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Yolanda Castañeda, BSN |
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Address:
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Telephone:
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214-363-3911 |
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Email:
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ycastane@retinafoundation.org |
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Affiliation:
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Name:
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Yolanda Castenada, BSN |
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Address:
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Telephone:
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214-363-3911 |
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Email:
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ycastane@retinafoundation.org |
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Affiliation:
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Name:
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Dennis R Hoffman, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Retina Foundation of the Southwest |
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Name:
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Eileen E Birch, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Retina Foundation of the Southwest |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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).
Age minimum:
351 Days
Age maximum:
379 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infant Development
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Intervention(s)
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Dietary Supplement: Corn oil placebo
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Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA)
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Primary Outcome(s)
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Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age
[Time Frame: 12 months intervention]
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Secondary Outcome(s)
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Maturation of cognition as assessed by the Wechsler Preschool and Primary Scale of Intelligence at 36 months of age
[Time Frame: After 24 months of intervention]
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Secondary ID(s)
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DSM #2009-1024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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