Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607684898541 Date of Registration: 31/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Vitamin D3 Supplementation on Breast Cancer Patients Treated with Radiotherapy
Official scientific title Effect of Vitamin D3 Supplementation on Breast Cancer Patients Treated with Radiotherapy
Brief summary describing the background and objectives of the trial Background: Breast cancer remains a major cause of cancer-related morbidity and mortality among women worldwide. Although radiotherapy is widely used in its management, treatment response can vary considerably, partly because of the development of radioresistance. Growing evidence suggests that vitamin D3 may influence tumor behavior and immune function, making it a potential supportive intervention during cancer treatment. Objective: To evaluate the effect of vitamin D3 supplementation on selected biochemical, molecular, and immunological markers in breast cancer patients receiving radiotherapy.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) VitD-BC
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 30/09/2024
Actual trial start date 31/10/2024
Anticipated date of last follow up 30/11/2025
Actual Last follow-up date 31/12/2025
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin D3 Capsules 10,000 IU per day during the radiotherapy course Oral administration of Vitamin D3 (Cholecalciferol) capsules at a dose of 10,000 IU daily,starting from the first fraction of radiotherapy and continuing until the completion of radiotherapy sessions. 30
Control Group Standard Adjuvant Radiotherapy cancer patients exposed to radiotherapy using a linear accelerator (LINAC) which customizes high energy X-rays with the dose delivered were 44 Gray over a period of 16 days in a daily fraction of 2.75 Gray delivered five times a week. Patients in the control arm received only the standard conventional adjuvant radiotherapy protocol for breast cancer, without any Vitamin D3 supplementation 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria were histologically proven malignancy, confirmed by an imaging study (X-ray, computed tomography scan). Patients who had previous radiotherapy were excluded from the study. Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 32 Year(s) 72 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/09/2024 IRB00010526
Ethics Committee Address
Street address City Postal code Country
165, Horreya Avenue, Hadara, Alexandria, Egypt Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vitamin D3 supplementation was associated with restoration of vitamin D3 status and favorable biological effects. Patients receiving Vitamin D3 demonstrated hematological stabilization, particularly improved hemoglobin levels, maintenance of magnesium homeostasis, preservation of lymphocyte counts, and regulation of CD8⁺ T-cell activity. In addition, Vitamin D3 supplementation was associated with suppression of VEGF levels, suggesting a potential inhibitory effect on tumor angiogenesis and modulation of the tumor microenvironment. after the last fraction of radiotherapy
Secondary Outcome Vitamin D3 supplementation was associated with restoration of vitamin D3 normal levels after the last fraction of radiotherapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ayadi El Mostakbel oncology center Acacia street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Lamis ZM. Altalahmeh 46 Anba Younes Street, Camp Shezar Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute Alexandria University 165 El-Horeya Avenue, El-Hadara Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sanaa El benhawy Sanaa.elbanhawi@alexu.edu.eg 01225418862 16 El Wazeer street - Moharem Bek
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Radiation Science Medical Research Institute Alexandria University
Role Name Email Phone Street address
Public Enquiries Lamise Altalahmeh Lameest@hebron.edu 01556183371 16 Anba Yunes Street
City Postal code Country Position/Affiliation
Alexandria Egypt Ph.D student at Radiation Sciences Department Medical Research institute
Role Name Email Phone Street address
Scientific Enquiries Sanaa El benhawy Sanaa.elbanhawi@alexu.edu.eg 01225418862 16 El Wazeer Street Moharem Bek
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Radiation Science Medical Research institute Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will not be available for public sharing to protect patient privacy and confidentiality, as per the institutional regulations Study Protocol Not applicable. Data will not be shared Not applicable. Data will not be shared
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/07/2026 Result - 27/07/2026 Result - 27/07/2026 Result - 27/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 20/07/2026 Update the age group selection to include the appropriate age categories including participants up to 72 years ago Middle Aged: 45 Year(s)-64 Year(s) Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 20/07/2026 remove all the other wording and leave only the recruitment center Patients with breast cancer were selected from those admitted to the Ayadi El Mostakbel oncology center, Acacia street , Alexandria, , Egypt Ayadi El Mostakbel oncology center, Acacia street , Alexandria, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 20/07/2026 Corrected and completed the contact address as requested No source, 165 El-Horeya Avenue, El-Hadara, Alexandria, , Egypt, Self Funded, Lamis ZM. Altalahmeh , 46 Anba Younes Street, Camp Shezar, Alexandria, , Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 2 27/07/2026 updated and re-loaded the summary results as requested by the registry 43699_30833_1046.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 3 27/07/2026 updated and re-loaded the summary results as requested by the registry 43699_30833_1047.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 4 27/07/2026 updated and re-loaded the summary results as requested by the registry 43699_30833_1048.pdf