Bafutto 2020.
| Study characteristics | ||
| Methods |
Study design: RCT (abstract) Setting: Brazil |
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| Participants |
State of disease/disease type: active CD Inclusion criteria: adults (aged 18–70 years) with moderate‐to‐severe CD on anti‐TNF therapy and 25(OH)D < 30 ng/mL Exclusion criteria: pregnancy, chronic kidney or liver disease, sarcoidosis, tuberculosis, hyper‐ or hypoparathyroidism, neoplasia, use of anticonvulsants, received calcium or vitamin D supplementation within preceding 6 months Age: mean: 41 years (Group 1); 37 (Group 2); 33 years (Group 3) Sex (males): 20% (Group 1); 80% (Group 2); 50% (Group 3) Number randomised: 10 (Group 1); 10 (Group 2); 10 (Group 3) Number analysed: not stated |
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| Interventions |
Group 1: vitamin D 2000 IU/week for 8 weeks Group 2: vitamin D 10,000 IU/week for 8 weeks Group 3: vitamin D 50,000 IU/week for 8 weeks |
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| Outcomes |
Duration of follow‐up: 52 weeks Outcomes
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| Notes |
Funding source: none Conflicts of interest: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Reported as randomised, although method of randomisation was not reported. |
| Allocation concealment (selection bias) | Unclear risk | No information to assess allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Reported as double‐blind trial, although method of blinding was not reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported as double‐blind trial, although method of blinding was not reported. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed intervention period of 8 weeks. |
| Selective reporting (reporting bias) | Unclear risk | All outcomes from methods reported, no clinical trial registration. |
| Other bias | Low risk | Balanced baseline characteristics and no other concerns. |