Personalized Vitamin D Supplementation for Reducing or Preventing Fatigue and Enhancing Quality of Life of Patients with Colorectal Tumor: Randomized Intervention Trial

ABSTRACT: Interventions: Group 1: Dekristol (ATC A11CC05, colecalciferol), PO (capsule), for 84 days. Individualized loading dose based on individual 25-hydroxyvitamin D levels and BMI (20,000 or 40,000 IU daily on day 1 to 11, in sum, on average approx. 180,000 IU) followed by a maintenance dose of 2,000 IU daily for the remaining days. Group 2: Control: Placebo for 84 days Primary outcome(s): Mean difference in FACIT-F fatigue subscale between intervention and placebo group in week 13 to 16. A mean difference = 3 FACIT-F fatigue subscale points will be considered a clinically relevant difference. Study Design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: treatment

DISEASE(S): Malignant Neoplasm Of Rectum,Fatigue Bei Patienten Mit Nicht-metastasierendem Kolorektalen Karzinom (union For International Cancer Control (uicc) Stufe I-iii, Icd-code C18-c21) Und Vitamin-d-insuffizienz/-mangel, Bei Denen Der Tumor Vor Nicht Mehr Als 9 Monaten Operativ Entfernt Wurde,Vitamin D Deficiency,Malignant Neoplasm Of Rectosigmoid Junction,Colorectal Cancer,Fatigue, Tumor-associatedquality Of Life,Vitamin D Decreased,Acute Upper Respiratory Infections,Malignant Neoplasm Of Colon,Fatigue In Patients With Colorectal Cancer (icd Codes C18-c20 And C21.8) Within 12 Months After A Colorectal Cancer Therapy (surgery, Chemotherapy And/ Or Radiation) And Not Optimal Vitamin D Status,Other Acute Lower Respiratory Infections,Fatigue In Patients With Non-metastatic Colorectal Cancer (union For International Cancer Control (uicc) Stage I-iii, Icd Code C18-c21) Within 9 Months After Surgical Removal Of Tumor And Vitamin D Insufficiency Or Deficiency,Cancer Fatigue

PROVIDER: 2436307 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR