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. 2023 Apr 14;2023(4):CD007986. doi: 10.1002/14651858.CD007986.pub3

Kean 2017.

Study characteristics
Methods Design: parallel trial
Comparison: omega‐3 PUFA vs placebo
Participants Inclusion criteria: children and adolescents aged 6 to 14 years, with a score of 15 or more on the DSM‐IV ADHD rating scale (73 with ADHD diagnosis), fluent in English, and non‐smoking
Exclusion criteria: primary medical diagnosis other than ADHD, oppositional defiant disorder or similar, behavioural disorders; currently taking any medication (other than stimulants if a formal diagnosis of ADHD or other behavioural disorder has been made); current or history of heart disease, or high blood pressure, or diabetes; health conditions that would affect food metabolism, including the following: food allergies, kidney disease, liver disease, and/or gastrointestinal diseases (e.g. irritable bowel syndrome, coeliac disease, peptic ulcers); pregnant or breastfeeding; unable to participate in all scheduled visits, treatment plan, tests, and other trial procedures according to the protocol; allergy to shellfish; epilepsy or photosensitivity
Number of participants: 144 (73 with ADHD; 65 completed)
Mean age: 8.82 years
Gender: 123 boys and 21 girls
ADHD subtypes: subsample analysis of combined high hyperactivity and inattention ‐ combined type (n = 65, 29 received omega‐3)
Using ADHD drugs at baseline: 52/144 taking pharmaceutical medications
Baseline scores: Conners Parent Rating Scale, inattention = 78.84 boys, 83.25 girls; hyperactivity = 80.85 boys, 80.75 girls
Setting: university, New Zealand, year/s not stated
Funding: study was funded by a grant from Pharmalink Pty Ltd
Interventions Intervention (29 participants): marine oil extract (PCSO‐524) under the brand names Lyprinol and Omega XL. The principal ingredients per 260‐milligram capsule were 50 mg eicosatetraenoic acid including EPA and 5.5 mg DHA; 3 capsules for participants ≤ 45 kg, 4 capsules for participants > 45 kg for 14 weeks
Control (36 participants): placebo, 3 to 4 capsules daily for 14 weeks
Outcomes
  1. ADHD symptoms measured at 14 weeks

    1. Conners Parent Rating Scale ‐ hyperactivity, inattention

  2. Behaviour at 14 weeks

    1. Conners Parent Rating Scale ‐ aggression, conduct; oppositional

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of a computer‐generated randomisation which was done by a neutral third party
Allocation concealment (selection bias) Low risk Blinding was achieved by enlisting a person outside of the project to code the treatments and maintain the key to this code until data collection was completed
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinding was achieved by enlisting a person outside of the project to code the treatments and maintain the key to this code until data collection was completed, "the placebo capsule matched the PCSO‐524® capsule in touch, taste, smell and size" (p406)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding was achieved by enlisting a person outside of the project to code the treatments and maintain the key to this code until data collection was completed
Incomplete outcome data (attrition bias)
All outcomes High risk ITT analyses was used for 112/144 but the data reported data were only for 65 participants with combined ADHD
Selective reporting (reporting bias) High risk Conners Parent Rating scores at 4, 8, 10 and 18 weeks and mood scores were not reported
Other bias High risk The study was funded by a grant from Pharmalink Pty Ltd.