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Table 1 Participant pathway and timeline and interventions

From: Protocol for an open-label feasibility study for a randomised controlled trial of vitamin D supplementation in Crohn’s Disease patients with vitamin D deficiency: D-CODE Feasiblity study

Procedures Routine Crohn's out-patient appointment Telephone contact
1 week
Feasibility trial visits Telephone and postal
   Follow-up visit 1
12 weeks ± 7 days
Follow-up visit 2
24 weeks ± 14 days
Follow-up visit 3
28 weeks ± 14 days
Vitamin D screening Baseline Eligibility Randomisation Intervention phase Final follow-up
Informed consent X   X      
Demographics X        
Medical history including current medication list X   X      
Confirmation of eligibility X    X     
Vitamin D dried blood spot test X        
Answer lifestyle and food frequency questions X        X
Telephone contact to arrange baseline appointment for feasibility trial   X       
Randomisation      X    
Pregnancy test as applicable    X      
Blood tests:
 Vitamin D (25(OH)D)    X    X X  
 Calcium    X    X X  
 Parathyroid hormone    X    X X  
 Albumin    X    X X  
 C-reactive protein    X    X X  
 Iron studies    X    X X  
 Ferritin    X    X X  
 Full blood count    X    X X  
 Hepcidin    X    x X  
 Vitamin D metabolites    X    X X  
Height    X      
Weight    X    X X  
Stool sample for faecal calprotectin a      x   x  
PROM 1 IBDQ      X   X  
PROM 2 EQ-5D-5L      X   X  
Clinical Assessment 3 CDAI      X X X  
Adverse event/reaction assessments       X X X
Dispensing of trial medication      X X   
Review of treatment diary       X X  
Compliance (pill count)       X X  
Assessment 4 Closing participant experience questionnaire - postal         X
  1. aIf a faecal calprotectin sample has been taken by the participants of the clinical team within the previous month, a further sample is not required for the study. The clinical result can be used.