Vaisman 2008.
Study characteristics | ||
Methods |
Design: parallel trial Comparator: omega‐3 PUFA vs placebo |
|
Participants |
Inclusion criteria: 1. aged 8 to 13 years; 2. had received a previous diagnosis of ADHD by a clinical psychiatrist, neurologist, or paediatrician Exclusion criteria: 1. significant sensory or neurological limitations; 2. epilepsy; 3. mental retardation; 4. psychosis; 5. pervasive developmental disorder; 6. taking medications with known central nervous system effects (including stimulants or dietary supplements other than vitamins); 7. a total Test of Variables of Attention Score more than 1.8 SD lower than age and gender means Number of participants: 60 Mean age: 9.3 years Gender: 45 boys and 15 girls at follow‐up ADHD subtypes: not stated Using ADHD drugs at baseline: 0% Baseline scores: Conners Rating Scale: PUFA = 15.8; placebo = 15.1 Setting: medical centre in Tel Aviv, Israel, 2004 to 2005 Funding: not stated |
|
Interventions |
Intervention (39 participants): PUFA for 3 months
Control (21 participants): placebo for 3 months; rapeseed oil supplement emulsified to a dairy chocolate‐flavoured spread containing 4 to 7 mg of citrus oil extract, administered as 25 g of spread per day for 3 months |
|
Outcomes |
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: A block randomisation with a block size of 3 was used. |
Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment was not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: The supplements appeared "identically appearing" (p1172); therefore, participants were probably blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: The supplements appeared identical and a parent‐rated scale was used. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: A per protocol analysis was used for 60 of 83 participants. |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes listed in paper and protocol appear to have been reported |
Other bias | Unclear risk | Comment: The principal author was a consultant to Enzymotec Pty Ltd and the Director was another author. |