Reading AbilityNCT02557477
Omega 3/6 Fatty Acids for Reading in Children
A study testing Omega 3/6 fatty acids in people with Reading Ability, run by Göteborg University.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Ability
- What is being tested?
- Omega 3/6 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mainstream schoolchildren in the 3rd school year (aged 9-10 years).
Who cannot join
- 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.
About this study
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
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)
Read the 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.
- Conditions
- Reading Ability
- Being tested
- Omega 3/6 fatty acids, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3/6 fatty acidsDietary supplement
Three Omega 3/6 capsules twice daily
PlaceboDietary supplement
Three placebo capsules twice daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Participants received 3 capsules of Omega 3/6 fatty acids twice daily Receives: Dietary Supplement: Omega 3/6 fatty acids |
| Placebo | Placebo comparator | Participants received 3 capsules of identical placebo (palm oil) twice daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reading ability
LOGOS test: Computerized test of several functions implicated in reading ability
Measured: 0, 3 and 6 months
Secondary outcomes (6)
Change in ADHD symptom severity
ADHD-Rating Scale IV: Parent-rated questionnaire measuring the DSM-IV ADHD symptom criteria
Measured: 0, 3 and 6 months
Change in learning ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in learning ability
Measured: 0,3 and 6 months
Change in memory ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in memory ability
Measured: 0, 3 and 6 months
Change in language/communication ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in language/communication ability
Measured: 0,3 and 6 months
Change in problem solving ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in problem solving ability
Measured: 0,3 and 6 months
Change in social ability
Social and Communication Disorders Checklist (SCDC): Parent-rated checklist measuring social ability
Measured: 0,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reading AbilityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557477
- Sponsor's protocol ID
- 381-09
- Status last verified
- Dec 2021
- First submitted
- 13 Sep 2015
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27545509
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02557477
- Acronym / sponsor ID
- 381-09
- Conditions
- Reading Ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Omega 3/6 fatty acidsParticipants received 3 capsules of Omega 3/6 fatty acids twice daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants received 3 capsules of identical placebo (palm oil) twice daily |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- mainstream schoolchildren in the 3rd school year (aged 9-10 years).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3/6 fatty acidsThree Omega 3/6 capsules twice daily | Dietary supplement | Active |
| PlaceboThree placebo capsules twice daily | Dietary supplement | Placebo |
Primary outcome
Change in reading ability
Time frame: 0, 3 and 6 months
LOGOS test: Computerized test of several functions implicated in reading ability
6 secondary outcomes
Change in ADHD symptom severity
Time frame: 0, 3 and 6 months
Change in learning ability
Time frame: 0,3 and 6 months
Change in memory ability
Time frame: 0, 3 and 6 months
Change in language/communication ability
Time frame: 0,3 and 6 months
Change in problem solving ability
Time frame: 0,3 and 6 months
Change in social ability
Time frame: 0,3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Derived from this study: PubMed 27545509Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3/6 fatty acids in people with Reading Ability, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reading ability (time frame: 0, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.