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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Allen Foundation Inc.
March of Dimes
Cures Within Reach
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01576783
First received: April 10, 2012
Last updated: July 11, 2017
Last verified: July 2017
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

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

Primary Outcome Measures:
  • Enrollment and Trial Completion [ Time Frame: Pre-baseline to 180 days post-randomization ]
    Primary Outcome for 1st stage of project funded by Allen Foundation, Inc: 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 ]
    Primary Outcome for 1st stage of project funded by Allen Foundation, Inc: The proportion of children who adhere to the assigned supplement or placebo.

  • Fatty Acid [ Time Frame: Baseline to 180 days post-randomization ]
    Primary Outcome for 1st stage of project funded by Allen Foundation, Inc: Change in plasma and RBC fatty acid concentrations.


Secondary Outcome Measures:
  • Development [ Time Frame: Baseline to 180 days post-randomization ]
    Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and HRSA: Changes in Bayley Scales of Infant and Toddler Development - 3rd edition scores from baseline to study visit 3.


Other Outcome Measures:
  • Behavior [ Time Frame: Baseline to 180 days post-randomization ]
    Differences in temperament (effortful control, activity level), social-emotional behavior, and sleep.

  • Body Composition [ Time Frame: Baseline to 180 days post-randomization ]
    Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds).

  • Long-term efficacy in improving cognition [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) cognitive outcome. This will be evaluated based on scores from the cognitive section of the Developmental Profile - 3.

  • Long-term efficacy in improving executive functions [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P).

  • Long-term efficacy in improving executive functions [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the ADHD DSM oriented subscale of the Child Behavior Checklist 1.5-5 (CBCL).

  • Other long-term outcomes: Pervasive Developmental Problems [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Pervasive Developmental Problems DSM oriented scale on the Child Behavior Checklist 1.5-5 (CBCL).

  • Other long-term outcomes: Language [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Communicative Development Inventory (CDI).

  • Other long-term outcomes: Sleep [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).

  • Other long-term outcomes: Sleep [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Children's Sleep Habits Questionnaire (CSHQ).

  • Other long-term outcomes: Growth [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using growth data.

  • Other long-term outcomes: Developmental Delay [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using reports/diagnoses of developmental delay.

  • Other long-term outcomes: Behavior [ Time Frame: Long-term effect (6 months +) after intervention completion ]
    Long-term (26-32 months of age) outcomes. This will be evaluated using reports/diagnoses of behavioral difficulties.


Enrollment: 377
Study Start Date: April 2012
Estimated Study Completion Date: July 2018
Primary Completion Date: April 2017 (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   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01576783

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
Allen Foundation Inc.
March of Dimes
Cures Within Reach
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Sarah Keim, PhD Nationwide Children's Hospital
  More Information

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: July 11, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017