Norouzi 2014.
| Methods | RCT, parallel, (MorDHA capsules vs unclear placebo), 14 months Summary risk of bias: moderate or high |
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| Participants | Patients with chronic traumatic spinal cord injury N: 55 intervention, 55 control. (analysed, intervention: 54 control: 50) Level of risk for CVD: low Men: 81.5% intervention, 82% control Mean age in years (SD): 51.15 (13.43) intervention, 54.12 (11.76) control Age range: 15‐74 years intervention, 30‐74 years control Smokers: 0% (exclusion criteria) 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: Iran Ethnicity: not reported |
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| Interventions | Type: supplement (n‐3 capsules) Comparison: EPA + DHA vs placebo (unclear what) Intervention: 2 MorDHA capsules (providing 870 mg DHA and 130 mg EPA) per day. Dose: 1 g/d DHA + EPA Control: 2 placebo capsules per day. Both capsules were similar in colour, shape, and taste. Both groups received one calcium capsules per day consisting of 1000 mg calcium and 400 IU vitamin D. Compliance: pill counts – compliance averaged 80% in both groups Duration of intervention: 14 months |
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| Outcomes | Main study outcome: professionals evaluation of neurological function Dropouts: 1 intervention, 5 control Available outcomes: functional measures (total and sub‐scales), BMI, leptin and adiponectin concentration. Response to contact: no |
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| Notes | Study funding: PhD university funding. Omega 3 capsules were provided by Minami Nutrition Co (Aartselaar, Belgium) and placebo capsules were supplied by Zahravi Pharmaceutical Co. (Tabriz, Iran). Calcium capsules were provided by Darou Pakhsh Pharm Co. (Tehran, Iran) Data were collected at the beginning of the study and after 14 months | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised using permuted balanced block randomisation method |
| Allocation concealment (selection bias) | Unclear risk | No further detail on allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated as double blind but content of placebo not stated and no report of attempt to mask n‐3 FA taste. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear, few details |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was 1 in intervention group, 5 in control group, so minor. "the two most common reasons for dropouts were experiencing GI side effects or difficulty to maintain scheduled clinic visits" |
| Selective reporting (reporting bias) | High risk | Some of the outcomes stated in the trial register are not reported. Registered March 2011, study start November 2010, completion April 2012 |
| Attention | Low risk | No difference between groups |
| Compliance | Unclear risk | Pill counts – compliance averaged 80% in both groups |
| Other bias | Low risk | None noted |