Personalized Vitamin D Supplementation for Reducing or Preventing Fatigue and Enhancing Quality of Life of Patients with Colorectal Tumor: Randomized Intervention Trial (VICTORIA)
Key facts
- Where
- NémetországSee the 5 sites
- Phase
- 3. fázis
Where in Németország
- Klinik Reinhardshöhe GmbHNémetországNo longer taking part
- Rehabilitation Clinic NiederrheinNémetországNo longer taking part
- Rehabilitation Clinic RosenbergNémetországNo longer taking part
- Rehazentrum Oberharz- Am Schwarzenbacher TeichNémetországNo longer taking part
- Waldburg- Zeil Kliniken Rehabilitationsklinik Bad SalzelmenNémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Trial code
- EU 2024-515420-37-01
- Record updated
- 2025. január 17.
- Original description
To test whether the proposed personalized vitamin D3 dosing regimen reduces or prevents fatigue (primary outcome) among CRC patients with not optimal vitamin D statusRead full original descriptionShow less
To test whether the proposed personalized vitamin D3 dosing regimen reduces or prevents fatigue (primary outcome) among CRC patients with not optimal vitamin D status
Inclusion: Age ≥ 18 years • CRC patients, both men and women • CRC therapy in last 12 months (surgical removal of tumor, radiation and/or chemotherapy (adjuvant or neoadjuvant)) • 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.
Exclusion: Sufficient vitamin D status (25(OH)D ≥ 60 nmol/L) • Severe renal impairment (eGFR < 30 ml/min/1,73 m²) • Hypercalcemia • Hypercalciuria • High-dose vitamin D3 therapy (≥ 2,000 IU daily or similar dosage which corresponds to ≥ 2,000 IU daily) • Therapy with vitamin D analogs • Topical therapy with vitamin D3 or vitamin D analogs • 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 year • Pseudohypoparathyreodism • Sarcoidosis • Therapy with cardiac glycosides • Therapy with high-dose calcium-supplements (> 1000 mg calcium daily) • Participation in another intervention trial • Pregnancy, planned pregnancy in next 12 weeks, or lactation • No use of adequate contraceptive measures in women of childbearing potential.