NCT00982462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 20, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

5.4 years

First QC Date

September 21, 2009

Last Update Submit

April 24, 2017

Conditions

Infant Development

Keywords

cognitionvisionimmunologyDHAARAinfantnutrition

Outcome Measures

Primary Outcomes (1)

  • Maturation of cognition as assessed by the Bayley Scales of Infant Development at 24 months of age

    12 months intervention

Secondary Outcomes (1)

  • Maturation of cognition as assessed by the Wechsler Preschool and Primary Scale of Intelligence at 36 months of age

    After 24 months of intervention

Study Arms (2)

Corn oil placebo

PLACEBO COMPARATOR

Micro-encapsulated powder containing corn oil placebo.

Dietary Supplement: Corn oil placebo

Long-chain polyunsaturated fatty acids

EXPERIMENTAL

Micro-encapsulated powder containing 1:1 ratio of the omega-3 long-chain polyunsaturated fatty acids, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid (ARA) from algal and fungal sources, respectively.

Dietary Supplement: Docosahexaenoic acid (DHA) and arachidonic acid (ARA)

Interventions

Docosahexaenoic acid (DHA) and arachidonic acid (ARA)DIETARY_SUPPLEMENT

Micro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods.

Also known as: Long-chain polyunsaturated fatty acids, omega-3 fatty acids, omega-6 fatty acids
Long-chain polyunsaturated fatty acids
Corn oil placeboDIETARY_SUPPLEMENT

Micro-encapsulated powder containing corn oil as the placebo.

Also known as: Long-chain polyunsaturated fatty acids, Omega-6 fatty acids
Corn oil placebo

Eligibility Criteria

Age351 Days - 379 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Related Links

MeSH Terms

Interventions

Docosahexaenoic AcidsArachidonic AcidFatty Acids, Omega-3Fatty Acids, Omega-6

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsArachidonic AcidsEicosanoidsFatty Acids, Essential

Study Officials

  • Eileen E Birch, PhD

    Retina Foundation of the Southwest

    PRINCIPAL INVESTIGATOR

  • Dennis R Hoffman, PhD

    Retina Foundation of the Southwest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sr Research Scientist

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 23, 2009

Study Start

January 20, 2011

Primary Completion

June 29, 2016

Study Completion

June 29, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

US(1)