Omega Tots: A Pilot Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

This study is enrolling participants by invitation only.
Allen Foundation Inc.
March of Dimes
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital Identifier:
First received: April 10, 2012
Last updated: March 11, 2015
Last verified: March 2015
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

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 the 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.

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 from baseline to study visit 3.

Other Outcome Measures:
  • Behavior [ Time Frame: Post-randomization ] [ Designated as safety issue: No ]
    Differences in temperament (effortful control, activity level), 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: 232
Study Start Date: April 2012
Estimated Primary Completion Date: December 2016 (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


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

Inclusion Criteria:

  1. Age 10-16 months (age corrected for prematurity) at baseline
  2. Discontinued regular breastfeeding and formula feeding at the time of randomization
  3. Gestational age < 35 completed weeks at birth
  4. English is primary language in home
  5. Informed consent obtained and signed
  6. Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance

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 identifier: NCT01576783

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
Allen Foundation Inc.
March of Dimes
Principal Investigator: Sarah Keim Nationwide Children's Hospital
  More Information

Responsible Party: Sarah Keim, Principal Investigator, Nationwide Children's Hospital Identifier: NCT01576783     History of Changes
Other Study ID Numbers: 183210 
Study First Received: April 10, 2012
Last Updated: March 11, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications processed this record on May 26, 2016