Wepner 2014.
| Methods | Randomised, double‐blind, placebo‐controlled study. Duration: 25 weeks of treatment, follow‐up examination at week 49 | |
| Participants | Participants (N = 42) with fibromyalgia and serum calcifediol levels < 32 ng/L; 30 completers (90% women): mean (± SD) age 48.4 ± 5.3 years, range 35‐55 years | |
| Interventions | Cholecalciferol (in triglyceride solution) 1200 or 2400 IU daily, depending on vitamin D level Placebo: triglyceride solution |
|
| Outcomes | Visual analogue pain scale, Short Form (36) Health Survey (SF‐36), Fibromyalgia Impact Questionnaire, all‐cause withdrawals, and baseline and end‐of‐trial 25‐hydroxyvitamin D levels | |
| Notes | Oxford Quality Score: R2, D2, W1 = 5/5 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number generator |
| Allocation concealment (selection bias) | Low risk | Random allocation done by statistician who was not involved in testing or treatment |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Cholecalciferol in triglyceride solution as active, triglyceride solution alone as placebo. Mock dose changes in placebo group |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 12/42 participants dropped out, completer analysis |
| Size | High risk | < 50 participants in each treatment arm |