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Table 3 Detailed schedule of all observations to be performed during the clinical trial

From: Protocol of the VICTORIA study: personalized vitamin D supplementation for reducing or preventing fatigue and enhancing quality of life of patients with colorectal tumor - randomized intervention trial

Procedure Screening Visit for eligibility Visit 1
Start of treatment
Visit 2
End of rehabilitation
Collection of data via questionnaire/ phone and blood/urine sampling by GP
Rehabilitation clinic Admission Discharge
Time-point of data assessment Day 1 Day 12–21 Week 13–16
Planned doses of vitamin D3 per day Individualized initial dose (20,000 or 40,000 IU, followed by 2000 IU per day) for day 1–11 Maintenance dose of 2000 IU per day for day 12–21
Inclusion/exclusion criteria   
Written informed consent    
Randomization     
Trial medication intake    
Subject diary regarding days of drug administration    
Physical examination (weight, height, waist circumference)    
Urinary pregnancy test for women of childbearing potential    
Assessment of CRC treatment   
Concomitant diseases / Medical history    
Concomitant medication   
Query about concomitant use of vitamin D3 or vitamin D analogs in self-medication in addition to trial medication    
Fatigue   
Functional well-being, QoL, infection frequency, and depression   
Blood sampling for biomarker efficacy and safety endpoints  
Urine sampling for safety endpoints  
(S)AE recording and protocol deviations  
  1. Abbreviations: CRC colorectal cancer; GP general practitioner; QoL Quality of life; SAE Serious adverse event