Nutristroke 2009.
| Methods | Nutristroke RCT, parallel, (diet rich in vitamins and omega 3 plus omega 3 supplement vs diet rich in vitamins and omega 3), 12 months Summary risk of bias: moderate or high |
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| Participants | People in a rehabilitation unit who had survived a stroke N: 38 intervention, 34 control. (analysed, intervention: 32 control: 20) Level of risk for CVD: high Men: 74% intervention, 56% control Mean age in years (SD): 61.3 (13.6) n‐3, 66.3 (11.4) n‐3 + antioxidant intervention, 68.4 (12.6) placebo, 65.1 (12.8) antioxidant – control Age range: not reported Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: not reported Location: Italy Ethnicity: not reported |
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| Interventions | Type: supplement (capsule) Comparison: fish oil vs unclear placebo Intervention: fish oil gelatin capsules including 250 mg DHA + 250 mg EPA. Dose: 0.5 g/d EPA + DHA Control: "identical to supplement but contained no antioxidants or polyunsaturated fatty acids" Compliance: appears to have been assessed at meetings or on the phone monthly, but results unclear Duration of intervention: 12 months |
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| Outcomes | Main study outcome: functional status in stroke survivors Dropouts: 6 intervention, 14 control Available outcomes: mortality and cardiovascular mortality, lipids (6 months), albumin and lymphocyte counts (6 months), Barthel Index (functional status), neurological impairment (not reported by intervention group), mobility, adiposity (no numerical data presented; quote: "there were no statistically significant differences in body weight, BMI, arm circumference and triceps skin fold at the different time points") Response to contact: not yet attempted |
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| Notes | 2 × 2 study that also had an antioxidant supplementary focus (supplementary vitamins C and E, beta carotene and polyphenols) Study funding: Italian Ministry of Health, Sigma‐Tau Health Science provided omega 3 capsules |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomized by means of a specific list" |
| Allocation concealment (selection bias) | Unclear risk | Randomisation methodology not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the placebo was identical to the supplement but contained no antioxidants or polyunsaturated fatty acids; no patient, research assistant, investigator or any other medical or nursing staff could distinguish the placebo from the supplements during the study". However, only one placebo discussed and unclear whether it was a placebo capsule (for omega 3) or pill (for antioxidants) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "assays were quality control checked by internal standard and calibration curve in a random and double blind way" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | High rates of dropouts |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trials registry entry found |
| Attention | Low risk | All assessments and treatments appear equal across the intervention groups |
| Compliance | Unclear risk | Appears to have been assessed at meetings or on the phone monthly, but results unclear |
| Other bias | Low risk | None noted |