Vitamin D on Tumor Response and Inflammatory MarkersPhase 4NCT07241247
Evaluation the of Role of Vitamin D Supplement on Tumor Response, Inflammation and Apoptosis in Patients With Stage II or III Colorectal Cancer Receiving Chemotherapy.
A Phase 4 study testing Vitamin D in people with Vitamin D on Tumor Response and Inflammatory Markers and Colo-rectal Cancer, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this work is to assess the of role of Vitamin D supplement on tumor response, inflammation and apoptosis in patients with stage II or III colorectal cancer receiving chemotherapy using BAX protein and Tumor necrosis factor - alpha (TNF- α) both are measured at baseline and after 6 months. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vitamin D on Tumor Response and Inflammatory Markers, Colo-rectal Cancer
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jul 2024to 10 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically and radiologically confirmed diagnosis of stage II or III colorectal cancer.
- Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
- Patients who received FOLFOX or XELOX as first line chemotherapy.
- Both genders.
- Age ≥18.
- Patients with adequate hematologic parameters (white blood cell count ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l).
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- Patients with normal renal functions.
- Patients with normal hepatic functions.
- Patients with sufficient 25(OH) Vitamin D level (30-100 ng/mL).
Who cannot join
- Patients with metastatic colorectal cancer (CRC).
- Patients with parathyroid disorders.
- Patients who are taking vitamin D-containing supplements (\>800 IU/day) unless they discontinued vitamin D supplementation at least 2 months prior to enrollment.
- Patients had a history of hypercalcemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Role of Vitamin D Supplement in Patients With Colorectal Cancer Receiving Chemotherapy
The aim of this work is to assess the of role of Vitamin D supplement on tumor response, inflammation and apoptosis in patients with stage II or III colorectal cancer receiving chemotherapy using BAX protein and Tumor necrosis factor - alpha (TNF- α) both are measured at baseline and after 6 months.
Read the detailed description
This randomized, controlled parallel study will be conducted on 44 patients with Stage II or III colorectal cancer. Patients will be recruited from Clinical Oncology
Department, Menoufia university Hospital, Menoufia, Egypt. The patients will be randomized using sealed envelope method into the following two groups:
Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).
Group II: (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
Markers to be measured:
- BAX protein as a marker for apoptosis will be measured at baseline and after 6 months.
- Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation will be measured at baseline and after 6 months.
- Being tested
- Vitamin D
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D supplement has effect on tumor response, inflammation and apoptosis
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months. Receives: Drug: Vitamin D |
| Control group | No intervention | (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the serum concentrations of the measured biological markers
- BAX protein as a marker for apoptosis
- Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start31 Jul 2024
- Primary completion10 Jun 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D on Tumor Response and Inflammatory MarkersStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Allah Ayman Aboelenean, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241247
- Sponsor's protocol ID
- 4/2024ONCO15
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Role of Vitamin D Supplement in Patients With Colorectal Cancer Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT07241247
- Acronym / sponsor ID
- 4/2024ONCO15
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this work is to assess the of role of Vitamin D supplement on tumor response, inflammation and apoptosis in patients with stage II or III colorectal cancer receiving chemotherapy using BAX protein and Tumor necrosis factor - alpha (TNF- α) both are measured at baseline and after 6 months.
Detailed description
This randomized, controlled parallel study will be conducted on 44 patients with Stage II or III colorectal cancer. Patients will be recruited from Clinical Oncology
Department, Menoufia university Hospital, Menoufia, Egypt. The patients will be randomized using sealed envelope method into the following two groups:
Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).
Group II: (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
Markers to be measured:
- BAX protein as a marker for apoptosis will be measured at baseline and after 6 months.
- Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation will be measured at baseline and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Drug: Vitamin D(Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months. |
| Control group | No intervention | –(Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically and radiologically confirmed diagnosis of stage II or III colorectal cancer.
- Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
- Patients who received FOLFOX or XELOX as first line chemotherapy.
- Both genders.
- Age ≥18.
Key exclusion criteria (4 listed)
- Patients with metastatic colorectal cancer (CRC).
- Patients with parathyroid disorders.
- Patients who are taking vitamin D-containing supplements (\>800 IU/day) unless they discontinued vitamin D supplementation at least 2 months prior to enrollment.
- Patients had a history of hypercalcemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DVitamin D supplement has effect on tumor response, inflammation and apoptosis | Drug | Vitamin D group |
Primary outcome
The change in the serum concentrations of the measured biological markers
Time frame: 6 months
* BAX protein as a marker for apoptosis * Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Prostate Cancer (Adenocarcinoma), Vitamin D on Tumor Response and Inflammatory Markers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Vitamin D on Tumor Response and Inflammatory Markers and Colo-rectal Cancer, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the serum concentrations of the measured biological markers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.