Kean 2017.
Study characteristics | ||
Methods |
Design: parallel trial Comparison: omega‐3 PUFA vs placebo |
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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 |
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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 |
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Outcomes |
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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. |