Methods | Randomised, double blind, placebo controlled trial. Trial duration: 12 months | |
Participants | Participants (n = 49) with rheumatoid arthritis of at least two years’ duration (average duration of disease 7 years). Mean age 52 years (range 18 to 69 years), 68% female | |
Interventions | 100 000 IU calciferol (no more details given) per day (n = 24) Placebo (n = 25) |
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Outcomes | Consumption of analgesics and antiinflammatory medicines, all cause withdrawals, and other outcomes | |
Notes | Oxford Quality Score: R1, D1, W1 = 3/5 Oxford Pain Validity Score: 11/16 |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated to be randomised. One of the authors chose whether participants received placebo or active treatment, but it is not stated by which method |
Allocation concealment (selection bias) | Unclear risk | One of the authors chose whether patients received placebo or active treatment (though it is not stated how) and was therefore possibly aware of the allocation. However, the authors arrived at their assessments independently and the other author’s opinion (not aware of allocation or blood calcium data) was adopted in case of disagreement |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Stated to be double blind. One of the authors was blinded but the other was possibly aware of treatment allocation |