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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Waldburg- Zeil Kliniken Rehabilitationsklinik Bad Salzelmen	Schönebeck	Germany

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	28.09.2020

Trial locations

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.

Investigated diseases:

Colorectal cancer

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 ID:

2024-515420-37-01

Protocol code:

DKFZ-2019-001

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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