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

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
  1. Phospholipid supplement enriched with n‐3 fatty acids (Enzymotec Ltd, Israel) containing 95 mg of DHA, 156 mg of EPA, 300 mg of phosphatidylserine, rosemary extract, ascorbyl palmitate, and mixed natural tocopherols (0.8% by weight), emulsified to a dairy chocolate‐flavoured spread containing 4 to 7 mg of citrus oil extract (to disguise taste) administered daily as 25 g of spread

  2. Fish oil supplement (Ocean Nutrition) containing 96 mg of DHA, 153 mg of EPA and tocopherol mixture (0.2% by weight) daily, emulsified to a dairy chocolate‐flavoured spread containing 4 to 7 mg of citrus oil extract (to disguise taste) administered daily as 25 g of spread 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
  1. Symptoms at 3 months

    1. Change in parent‐rated abbreviated Conners Rating Scale

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.