Ivity 2015.
Study characteristics | ||
Methods |
Design: parallel trial Comparison: omega‐3 PUFA supplement vs placebo |
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Participants |
Inclusion criteria: 1. children aged between 5 and 12 years; 2. diagnosed by a qualified healthcare professional (paediatrician, psychiatrist, or psychologist) as having any of the subtypes of ADHD, according to DSM‐IV criteria; 3. of normal intelligence according to parent report or an IQ of at least 70 on a standardised test. Participants could present with comorbid conditions, including oppositional defiant disorder, conduct disorder, anxiety disorders, mood disorders, and learning disorders. Exclusion criteria: 1. taking medication to treat ADHD or other prescription medication, or both; 2. consuming any special diets or supplements that contained DHA; 3. diagnosed with foetal alcohol syndrome or autism Number of participants: not stated Median age: not stated Gender: not stated ADHD subtypes: not stated Using ADHD drugs at baseline: 0% Baseline scores: not stated Setting: mental health organisation, Canada, year/s not stated Funding: not stated |
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Interventions |
Intervention (13 participants): omega‐3 PUFA for 4 months; 2 capsules (children weighing 40 to 79 pounds) or 3 capsules (children weighing 80 to 140 pounds) of Omega‐3 Think (Genuine Health, Toronto, Canada) capsules (250 mg of DHA and 100 mg of EPA) Control (13 participants): placebo for 4 months; capsules containing olive oil |
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Outcomes |
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Notes | Only inattention at 8 weeks was reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Both the supplement and placebo capsules were counted and put into identical opaque Nalgene pill bottles by the assistant and numerically coded |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method of blinding not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of blinding not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 30/56 LTFU |
Selective reporting (reporting bias) | High risk | Only inattention at 8 weeks was reported |
Other bias | High risk | Demographic characteristics of participants, and reasons for withdrawal/drop‐out were not reported |