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. 2023 Oct 2;2023(10):CD011806. doi: 10.1002/14651858.CD011806.pub2

Bafutto 2020.

Study characteristics
Methods Study design: RCT (abstract)
Setting: Brazil
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
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
Outcomes Duration of follow‐up: 52 weeks
Outcomes
  • Clinical relapse (CDAI > 150, calprotectin > 300 µg/g, CT evidence of inflammation)

  • Vitamin D concentration

  • CRP

  • Faecal calprotectin

  • Quality of life

Notes Funding source: none
Conflicts of interest: none
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.