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.

November 19, 2025 updated by: Menna Allah Ayman Aboelenean, Tanta University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Menofia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).
  • Patients with normal renal functions.
  • Patients with normal hepatic functions.
  • Patients with sufficient 25(OH) Vitamin D level (30-100 ng/mL).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D group
(Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
Drug: Vitamin D
Vitamin D supplement has effect on tumor response, inflammation and apoptosis
No Intervention: Control group
(Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Actual)

June 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2024ONCO15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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