The Middlesbrough study: a randomised, controlled trial of dietary supplements with omega-3/omega-6 fatty acids in mainstream school children

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: Active treatment: dietary supplement (Eye q): Omega‐3/omega‐6 dietary supplement in capsule form, six times/day providing 558 mg Eicosapentaenoic Acid (EPA), 174 mg Docosahexaenoic Acid (DHA), 60 mg Gamma Linolenic Acid for duration of trial. Control group: dietary supplement (placebo): Placebo containing medium‐chain triglycerides derived from olive oil, 4% of the capsule comprised EPA and DHA to ensure a fishy taste and carrot oil macerate for colouring. After three months this group crossed over to the active treatment. The duration of the treatment was six months (one‐way crossover from placebo to active after three months) with staggered entry over two months. Assessments for primary/secondary outcome measures were completed at baseline, three and six months. A random sample of 50 participants will be tracked until they leave school, aged 16/18. Follow up will involve monitoring participants' attainments in National Tests (KS 1, 2 and 3 results and performance at KS4 via GCSE/Vocational qualifications). CONDITION: Poor concentration, hyperactivity, learning abilities and working memory ; Mental and Behavioural Disorders ; Mild child/adolescent cognitive disorder PRIMARY OUTCOME: 1. Measurement of change in working memory, confirmed by results from Wechsler Intelligence Scale for Children (WISC‐III UK) digit span assessment; time frame: 6 months ; 2. Measurement of change in reading ability, using the Wechsler Objective Reading Dimensions (WORD) assessment; time frame: 6 months SECONDARY OUTCOME: 1. Measuring a range of behavioural parameters including cognitive problems, hyperactivity, social problems, ADHD and emotional lability as identified by parents using the Conners' Parent Rating Scales‐Long Version (CPRS‐L); time frame: 6 months ; 2. Measuring a range of behavioural parameters including cognitive problems, hyperactivity, social problems, ADHD and emotional lability as identified by teachers using the Conners' Teacher Rating Scales‐Long Version (CTRS‐L); time frame: 6 months INCLUSION CRITERIA: Participants attend mainstream school.
Epistemonikos ID: e84b03aaf65de6788297bfe052b368fefa748bcc
First added on: Aug 21, 2024