Zhang 2017.
Methods | RCT, parallel, (n‐3 DHA vs n‐6 LA), 12 months Summary risk of bias: moderate to high |
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Participants | Otherwise healthy elderly people with mild cognitive impairment. N: 120 intervention, 120 control (analysed, intervention: 110 control: 109) Level of risk for CVD: low Men: 35.8% intervention, 34.2% control Mean age in years (SD): 74.5 (2.65) intervention, 74.6 (3.31) control Age range: eligibility criteria were age 65‐85 years at trial start Smokers: 59.17% intervention, 61.67% control Hypertension: 9.17% intervention, 7.50% control 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: China Ethnicity: assumed Chinese |
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Interventions | Type: supplement (capsule) Comparison: DHA vs corn oil (n‐6) Intervention: 1 capsule twice a day, with meals, including 2 g algal DHA (45‐55% DHA by weight). Martek Biosciences, Columbia, MD. Dose: ˜1 g/d DHA Control: corn oil, orange‐flavoured and orange colour to protect the study blind Compliance: participants were asked to return any remaining tablets. Compliance was defined as a ratio (actually taken/should have taken). Achieved 97% for intervention, 95% for control. Serum levels of DHA also measured, DHA at 6 months barely higher in intervention than in controls Duration of intervention: 12 months |
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Outcomes | Main study outcome: cognitive function and hippocampal volume Dropouts: 10 intervention, 11 control Available outcomes: mortality, cognitive outcomes and cerebral volume measurements Response to contact: no reply to date |
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Notes | Study funding: Chinese Nutrition Society (CNS) Nutrition Research Foundation‐ DSM Research Fund | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated, also statistics analyst ignorant to this study used random number table |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo capsules … identical in appearance. All capsules were orange‐flavoured and orange colour to protect the study blind . Packaged into identical pots, each containing 180 capsules, and labelled by staff who were not involved in the study. A blinding key linked each participant to his or her assigned treatment. This key was kept by an investigator not involved in any data collection or analyses, in a secure electronic file. The code was revealed at the completion of the trial following analyses of the main study aims. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All project staff were unaware of group assignments until the completion of the trial and after data analysis |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | They did not describe how they imputed missing data (lost contact with patients, but called this an ITT analysis). Overall well matched and not high attrition. |
Selective reporting (reporting bias) | Low risk | Registered trial prospectively. Outcomes match protocol |
Attention | Low risk | "Adherence was encouraged and monitored throughout the trial by telephone assessment at 15 time points, and by blood assay at baseline" 6 months and 12 months. This and assessments were described as same for both arms. |
Compliance | Unclear risk | Quote: "participants were requested to return any remaining tablets in order to measure compliance, together with the replenishment of capsules for the following month." Compliance … defined "as a ratio = actually taken/should have taken". "Adherence was encouraged and monitored throughout the trial by telephone assessment at 15 time points, and by blood assay at baseline" 6 months and 12 months On compliance tree, leads to "No, because no P values were supplied" therefore risk of compliance bias unclear |
Other bias | Unclear risk | Although the register says single blind, the publication very clearly describes a double‐blind RCT |