Omega Tots: a Pilot Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Allen Foundation
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01576783
First received: April 10, 2012
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.


Condition Intervention Phase
Preterm Birth
Child Development
Drug: DHA+AA
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega Tots: a Pilot Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Enrollment and Trial Completion [ Time Frame: Pre-baseline to 180 days post-randomization ] [ Designated as safety issue: No ]
    The number of children who enroll in the trial and proportion who return for study visits 2 and 3.

  • Adherence [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]
    The proportion of children who adhere to the assigned supplement or placebo.

  • Fatty Acid [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]
    Change in plasma and RBC fatty acid concentrations from baseline to study visit 2.


Secondary Outcome Measures:
  • Development [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]
    Changes in Bayley Scales of Infant and Toddler Development - 3rd edition scores (cognitive, language, and motor sub-scales) from baseline to study visit 3.


Other Outcome Measures:
  • Behavior [ Time Frame: Post-randomization ] [ Designated as safety issue: No ]
    Differences in temperament, social-emotional behavior, and sleep.

  • Body Composition [ Time Frame: Baseline to 180 days post-randomization ] [ Designated as safety issue: No ]
    Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds).


Estimated Enrollment: 112
Study Start Date: April 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA arm
DHA+AA supplement
Drug: DHA+AA
200 mg DHA + 200 mg AA per day, for 6 months
Placebo Comparator: Placebo
Corn oil supplement
Dietary Supplement: Placebo
400 mg corn oil per day for 6 months

  Eligibility

Ages Eligible for Study:   10 Months to 16 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 10-16 months (age corrected for prematurity) at baseline
  2. Discontinued breastfeeding and formula feeding at the time of randomization
  3. Gestational age < 35 completed weeks at birth
  4. English is primary language at home
  5. Informed consent obtained and signed

Exclusion Criteria:

  1. Feeding problems
  2. Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
  3. Weight < 5th or > 95th percentile for age, per WHO growth charts
  4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
  5. Plans to move out of the area within the next 6 months
  6. Known corn allergy
  7. Known soy allergy
  8. Known fish allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576783

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
Allen Foundation
Investigators
Principal Investigator: Sarah Keim Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Sarah Keim, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01576783     History of Changes
Other Study ID Numbers: 183210
Study First Received: April 10, 2012
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014