Omega 3/6 Fatty Acids for Reading in Children

NCT02557477 | Completed

• 1 other identifier: 381-09
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Reading Ability

Outcome Measures

Primary Outcomes (1)

• Change in reading ability

  LOGOS test: Computerized test of several functions implicated in reading ability

  0, 3 and 6 months

Secondary Outcomes (6)

• Change in ADHD symptom severity

  0, 3 and 6 months

• Change in learning ability

  0,3 and 6 months

• Change in memory ability

  0, 3 and 6 months

• Change in language/communication ability

  0,3 and 6 months

• Change in problem solving ability

  0,3 and 6 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Participants received 3 capsules of Omega 3/6 fatty acids twice daily

Dietary Supplement: Omega 3/6 fatty acids

Placebo

PLACEBO COMPARATOR

Participants received 3 capsules of identical placebo (palm oil) twice daily

Dietary Supplement: Placebo

Interventions

Omega 3/6 fatty acids DIETARY_SUPPLEMENT

Three Omega 3/6 capsules twice daily

Active

Placebo DIETARY_SUPPLEMENT

Three placebo capsules twice daily

Placebo

Eligibility Criteria

• Age: 9 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Vifor Pharma: collaborator

Related Publications (1)

• Johnson M, Fransson G, Ostlund S, Areskoug B, Gillberg C. Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden. J Child Psychol Psychiatry. 2017 Jan;58(1):83-93. doi: 10.1111/jcpp.12614. Epub 2016 Aug 22.

  PMID: 27545509 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: September 23, 2015
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 27, 2021

Record last verified: 2021-12