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Study on Vitamin D3 and Glycerol for Reducing Fatigue in Colorectal Cancer Patients with Low Vitamin D Levels After Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have been treated for colorectal cancer and are experiencing fatigue. Colorectal cancer is a type of cancer that affects the colon or rectum. Fatigue is a common issue for patients who have undergone treatments such as surgery, chemotherapy, or radiation. The study aims to explore whether a personalized dosage of Vitamin D3, also known as colecalciferol, can help reduce or prevent fatigue in these patients. Vitamin D3 is a form of vitamin D that is important for maintaining bone health and supporting the immune system.

Participants in the study will receive either Vitamin D3 or a placebo capsule. The study will last for a period of 12 weeks, during which the effects of Vitamin D3 on fatigue levels will be monitored. The goal is to determine if Vitamin D3 can improve the quality of life for patients by reducing fatigue. The study is designed to provide insights into how personalized Vitamin D supplementation might benefit those with low vitamin D levels following colorectal cancer treatment.

The trial is named VICTORIA, which stands for "Personalized Vitamin D Supplementation for Reducing or Preventing Fatigue and Enhancing Quality of Life of Patients with Colorectal Tumor." It is a randomized intervention trial, meaning that participants are randomly assigned to receive either the Vitamin D3 treatment or the placebo. The main objective is to assess the difference in fatigue levels between the two groups at the end of the study period. This research could potentially lead to new strategies for managing fatigue in colorectal cancer patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, recent colorectal cancer therapy, and vitamin D levels.

    Participants must be at least 18 years old, have undergone colorectal cancer therapy within the last 12 months, and have vitamin D levels below 60 nmol/L.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: the intervention group receiving colecalciferol (vitamin D3) or the placebo group receiving a placebo capsule.

    This process ensures that the effects of the vitamin D3 supplementation can be accurately compared to the placebo.

  3. Step 3

    Treatment phase

    Participants in the intervention group receive colecalciferol orally. The dosage and frequency are personalized based on individual needs to optimize vitamin D levels.

    The placebo group receives a capsule that does not contain active vitamin D3. This phase lasts for the duration of the study.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants are monitored for changes in fatigue levels and overall quality of life.

    Assessments are conducted at regular intervals to track progress and ensure safety.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment is conducted to evaluate the mean difference in fatigue levels between the intervention and placebo groups.

    This assessment helps determine the effectiveness of the personalized vitamin D3 dosing regimen in reducing or preventing fatigue.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Must be a **patient with colorectal cancer (CRC)**, which is a type of cancer that affects the colon or rectum.
  • Must have received **CRC therapy** in the last 12 months. This includes surgery to remove the tumor, radiation, or chemotherapy, which are treatments to fight cancer.
  • Must plan to have at least **3 weeks of in-patient rehabilitation** in a cooperating clinic. Rehabilitation is a program to help you recover and improve your health after treatment.
  • Must have **sufficient knowledge of the German language** and the mental ability to understand and agree to participate in the study. This means you should be able to read, understand, and sign a consent form and follow the study's requirements.

Who cannot join the trial?

5 criteria

  • Patients who do not have fatigue related to colorectal cancer treatment.
  • Patients who have not undergone colorectal cancer therapy, which includes surgery, chemotherapy, or radiation, in the last 12 months.
  • Patients with optimal vitamin D levels. Optimal levels mean having 25-hydroxyvitamin D (25(OH)D) levels of 60 nmol/L or higher. Vitamin D is important for bone health and immune function.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups that may need special protection or care.
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Investigated drugs

Vitamin D3 is being studied to see if it can help reduce or prevent fatigue in patients with colorectal tumors. The trial is testing a personalized dosing regimen to see if it improves the quality of life for these patients, especially those who do not have optimal levels of vitamin D.

What is already known about the treatment

Vitamin D3 – This medication is administered orally, typically in the form of capsules or tablets. It is currently being studied in clinical trials for its potential to reduce or prevent fatigue in patients with colorectal cancer who have suboptimal vitamin D levels. The main therapeutic indication is to improve energy levels and enhance the quality of life in these patients. At the molecular level, Vitamin D3 works by regulating calcium and phosphate balance in the body, which is crucial for maintaining healthy bones and supporting immune function. It is classified as a vitamin supplement and is widely recognized in medical literature for its role in bone health and immune support.

Investigated diseases

Fatigue in patients with colorectal cancer – This condition involves a persistent feeling of tiredness or exhaustion that is not relieved by rest. It is commonly experienced by patients who have undergone treatment for colorectal cancer, such as surgery, chemotherapy, or radiation. The fatigue can affect daily activities and overall quality of life. It may be linked to the cancer itself, the treatments, or other factors like nutritional deficiencies. In this context, it is associated with suboptimal levels of vitamin D. The fatigue can vary in intensity and duration among different individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515420-37-01Protocol codeDKFZ-2019-001Estimated enrolment456 patientsSponsorDeutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts

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