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Omega 3/6 Fatty Acids for Reading in Children

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ClinicalTrials.gov Identifier: NCT02557477
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves mainstream schoolchildren's reading ability. The secondary objective was to assess whether Omega 3/6 improves cognitive functions such as attention, memory, learning, language/communication, problem solving and social ability.This was a 3-month randomised, double-blind, placebo-controlled study followed by one-way crossover (placebo to active treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo. All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities. Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and problem solving); Social and Communication Disorders Checklist (to evaluate social ability)

Condition or disease Intervention/treatment Phase
Reading Ability Dietary Supplement: Omega 3/6 fatty acids Dietary Supplement: Placebo Phase 4

Detailed Description:
This was a 3-month randomized, double-blind, placebo-controlled study (Period 1) followed by one-way crossover (placebo to active treatment) for an additional 3 months (Period 2). Participants were randomized to receive three Omega 3/6 capsules twice daily (corresponding to a daily dose of 558 mg EPA, 174 mg DHA, and 60 mg gamma-linolenic acid) or identical placebo capsules (palm oil). All daily doses were taken at home supervised by the parents. All outcome measures were assessed at baseline and at the 3- and 6-month follow-up visits. The participants were mainstream schoolchildren in the 3rd school year (aged 9-10 years). Exclusion criteria were continuous supplementation of Omega-3 fatty acids for periods longer than 1 month during the previous year, significant medical conditions (e.g. diabetes, epilepsy), intellectual disability, attention-deficit hyperactivity disorder (ADHD) diagnosis, psychoactive medication, or substance use.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega 3/6 Fatty Acids for Reading in Children: A Randomised, Double-blind, Placebo-controlled Trial in 9-year-old Mainstream Schoolchildren in Sweden
Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Participants received 3 capsules of Omega 3/6 fatty acids twice daily
Dietary Supplement: Omega 3/6 fatty acids
Three Omega 3/6 capsules twice daily

Placebo Comparator: Placebo
Participants received 3 capsules of identical placebo (palm oil) twice daily
Dietary Supplement: Placebo
Three placebo capsules twice daily




Primary Outcome Measures :
  1. Change in reading ability [ Time Frame: 0, 3 and 6 months ]
    LOGOS test: Computerized test of several functions implicated in reading ability


Secondary Outcome Measures :
  1. Change in ADHD symptom severity [ Time Frame: 0, 3 and 6 months ]
    ADHD-Rating Scale IV: Parent-rated questionnaire measuring the DSM-IV ADHD symptom criteria

  2. Change in learning ability [ Time Frame: 0,3 and 6 months ]
    FTF scale: Parent-rated questionnaire, domain measuring problem scores in learning ability

  3. Change in memory ability [ Time Frame: 0, 3 and 6 months ]
    FTF scale: Parent-rated questionnaire, domain measuring problem scores in memory ability

  4. Change in language/communication ability [ Time Frame: 0,3 and 6 months ]
    FTF scale: Parent-rated questionnaire, domain measuring problem scores in language/communication ability

  5. Change in problem solving ability [ Time Frame: 0,3 and 6 months ]
    FTF scale: Parent-rated questionnaire, domain measuring problem scores in problem solving ability

  6. Change in social ability [ Time Frame: 0,3 and 6 months ]
    Social and Communication Disorders Checklist (SCDC): Parent-rated checklist measuring social ability



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mainstream schoolchildren in the 3rd school year (aged 9-10 years).

Exclusion Criteria:

  • continuous supplementation of Omega-3 fatty acids for periods longer than 1 month during the previous year
  • significant medical conditions (e.g. diabetes, epilepsy)
  • intellectual disability
  • attention-deficit hyperactivity disorder (ADHD) diagnosis, psychoactive medication, or substance use.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02557477     History of Changes
Other Study ID Numbers: 381-09
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015