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

Start 28 Sep 2020 · End 15 Jul 2025 · Status Ended · 1 EU/EEA countries · 5 sites · Protocol DKFZ-2019-001

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ended

Participants planned 456

Countries 1

Sites 5

Fatigue in patients with colorectal cancer (CRC) (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 (25-hydroxyvitamin D (25(OH)D) levels < 60 nmol/L)

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

Key facts

Sponsor: Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trial duration: 28 Sep 2020 → 15 Jul 2025
Decision date (initial): 2025-01-17
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-515420-37-01
EudraCT number: 2019-000502-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Therapy, Efficacy, Prophylaxis

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

Conditions and MedDRA coding

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

• 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 criteria 1

• 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

• Mean difference in FACIT-F fatigue subscale between intervention and placebo group at trial week 13-16

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Colecalciferol

SCP102627814 · ATC

Active substance: Colecalciferol
Substance synonyms: CHOLECALCIFEROL, VITAMIN D3, COLECALCIPHEROL
Route of administration: ORAL
Max daily dose: 40000 IU international unit(s)
Max total dose: 566000 IU international unit(s)
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: A11CC05 — COLECALCIFEROL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The IMP is over-encapsulated.

Placebo 1

placebo capsule

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts

Sponsor organisation: Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
Address: Im Neuenheimer Feld 280, Neuenheim Neuenheim
City: Heidelberg
Postcode: 69120
Country: Germany

Scientific contact point

Organisation: Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
Contact name: Deputy Scientific Coordinator

Public contact point

Organisation: Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
Contact name: Deputy Scientific Coordinator

Locations

1 EU/EEA country · 5 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ended	456	5
Rest of world	—	0	—

Investigational sites

Germany

5 sites · Ended

Waldburg- Zeil Kliniken Rehabilitationsklinik Bad Salzelmen

Oncology, Badepark 5 39218 Schönebeck, Germany

Rehazentrum Oberharz- Am Schwarzenbacher Teich

Oncology, Schwarzenbacher Str. 19, Germany

Rehabilitation Clinic Rosenberg

Oncology, Hinter dem Rosenberg 1, Germany

Klinik Reinhardshöhe GmbH

Oncology, Quellenstraße 8-12 34537 Bad Wildungen, Germany

Rehabilitation Clinic Niederrhein

Oncology, Hochstraße 13-19, Germany

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2020-09-28		2020-09-28	2025-04-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	Protocol_V6_2024-515420-37-00_for publication	1
Recruitment arrangements (for publication)	Participating Sites and Facilities in the VICTORIA trial	1
Recruitment arrangements (for publication)	Recruitment procedure_extract from the protocol	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_adults_GER	1
Summary of Product Characteristics (SmPC) (for publication)	E1_Apr2024_Dekristol_VitD3_20000_IU	1
Summary of Product Characteristics (SmPC) (for publication)	E1_Sep2023_Dekristol_VitD3_500IE_1000IU	1
Synopsis of the protocol (for publication)	D2_Protocolsynopsis_V5_2024-515420-37-00_GER_for publication	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-12-27	Germany	Acceptable 2025-01-10	2025-01-17