Raftery 2013.
| Methods | RCT, double‐blinded | |
| Participants | Crohn’s disease, in remission and on stable drug therapies for at least 1 month at study entry Exclusion criteria: Symptomatic CD (CDAI > 150); pregnancy; previous extensive small bowel research; presence of an ileostomy or colostomy; known hypersensitivity to vitamin D; hypercalcaemia; those currently using supplemental vitamin D > 800 IU/D; diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active lymphoma, short bowel syndrome; antibiotic use in the 4 weeks prior to enrollment; current use of bisphosphonates; renal impairment, diabetes mellitus; participants participating in a concurrent RCT; alcohol dependency A total of 27 participants were randomised to the intervention (vitamin D3, n = not reported) or control group (placebo, n = not reported) Loss to follow‐up: Not reported |
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| Interventions | Vitamin D3 Dosing regimen: 2000 IU per day Mode of delivery: Oral Duration: 3 months Setting: 2 centres in the Republic of Ireland Comparision treatment: Placebo (soya bean oil) Co‐interventions: None |
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| Outcomes | Fatigue was assessed using the MFI. Quality of life was assessed using the IBDQ. Adverse events were not assessed. Other outcomes assessed: Change in hand grip strength; disease activity (CDAI), FBC, CRP, serum 25OHD Assessment time points: Baseline and month 3 |
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| Notes | No additional information supplied by the author | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind but no further information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes but details of blinding not explicit |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants included in the analysis was not reported. |
| Selective reporting (reporting bias) | High risk | Reported only the difference in muscle strength scores for the intervention and control groups. Changes in fatigue and quality of life scores from baseline to month 3 presented for those who achieved 25OHD levels ≥ 75nmol/L compared to those with 25OHD levels < 75nmol/L only. |
| Other bias | Unclear risk | Baseline group characteristics not reported |