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Table 1 Inclusion and exclusion criteria

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

Inclusion Criteria Exclusion Criteria
• Age ≥ 18 years
• Non-metastatic CRC patients (UICC stage I-III)
• Within 9 months after surgical removal of tumor
• At least 3 weeks in-patient rehabilitation in a cooperating clinic is planned
• Sufficient knowledge of the German language and mental capabilities to be able to give written informed consent and comply with the study requirements
• No season adapted vitamin D insufficiency or deficiency (see Table 2 for definition)
• BMI > 40 kg/m2
• Severe anemia (Hemoglobin < 8.0 g/dl)
• Severe renal impairment (eGFR < 30 ml/min/1,73 m2 calculated with the CKD-EPI equation [26])
• Hypercalcemia (Albumin-corrected serum calcium > 2.65 mmol/L)
• Hypercalciuria (Random urine calcium ≥0.60 mmol/mmol creatinine)
• High-dose vitamin D3 therapy (≥ 2000 IU daily or similar dosage which corresponds to ≥2000 IU daily)
• Therapy with vitamin D analogs
• Topical therapy with vitamin D3 or vitamin D analogs
• Therapy with high-dose calcium supplements (> 1000 mg calcium daily)
• Therapy with cardiac glycosides
• Hypersensitivity towards ingredients in Dekristol® 20,000/1000 I.E.: peanuts, soy, gelatin, lactose, maize starch or sucrose or ingredients in the placebo capsules (mannitol, silicon dioxide)
• Nephrolithiasis with symptoms in the last 12 months
• Pseudohyperparathyreodism
• Sarcoidosis
• Participation in another interventional trial
• Pregnancy, planned pregnancy in the next 12 weeks, or lactation
• No use of adequate contraceptive measures in women with childbearing potential
  1. Abbreviations: BMI body mass index; CKD-EPI Chronic Kidney Disease Epidemiology Collaboration; eGRF estimated glomerular filtration rate; UICC Union for International Cancer Control