Rodriguez 2019.
Study characteristics | ||
Methods |
Design: parallel trial Comparison: omega‐3 PUFA vs placebo |
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Participants |
Inclusion criteria: 1. boys and girls between 6 and 18 years of age; 2. DSM‐5 diagnosis of ADHD confirmed by a trained researcher using the Diagnostic Interview Schedule for Children‐Parent Version (DISC‐P) with any subtype of ADHD (hyperactive‐impulsive, inattentive, combined hyperactive‐inattentive) Exclusion criteria: 1. total IQ scores lower than 70 and greater than 130; 2. blood coagulation disorders, cognitive impairment, or autism spectrum disorder; 3. intolerance to fish proteins, and treatment with dietary supplements containing omega‐6 or omega‐3 PUFAs during the preceding month Number of participants: not stated Mean age: 11.7 years Gender: not stated ADHD subtypes: not stated Using ADHD drugs at baseline: more than 70% were using psychostimulant medication Baseline: not stated Comorbid conditions: present in 12 and 4 participants in the DHA and placebo groups, respectively Setting: faculty of psychology, Spain, year/s not stated Funding: not stated |
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Interventions |
Intervention (32 participants): each sachet of omega‐3 fatty acids contained: 1000 mg DHA, 90 mg EPA, and 150 mg docosapentaenoic acid. Doses were 1 sachet/day in children weighing ≤ 32 kg and 2 sachets/day in those weighing > 32 kg for 6 months Control (34 participants): placebo sachets were composed of the same amount of olive oil with banana flavour to give a similar taste and smell |
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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 | Randomization (1:1) was performed according to a computer‐generated random sequence |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants, parents, and investigators assessing outcome measures were blind to the intervention condition |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants, parents, and investigators assessing outcome measures were blind to the intervention condition |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT analyses were referred to in paper but were not reported, 19/85 lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All relevant outcomes listed in paper were reported |
Other bias | Unclear risk | Baseline scores were similar for PUFA and placeo but other comparisons between groups were not reported |