Vitamin D supplementation and breast cancer prevention

Assessment the effect of vitamin D supplementation on plasma vitamin D levels, inflammatory and antioxidant biomarkers and factors associated with cell proliferation, differentiation, damage and appopotosis in breast cancer survivor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017091736244N1

Enrollment

165

Registered

2017-11-10

Start date

2016-02-02

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Survivour.

Interventions

Supplement therapy with daily dose of 4000 IU cholecalciferol for 12 weeks.

Treatment - Drugs

Supplement therapy with daily dose of 4000 IU cholecalciferol for 12 weeks

Eligibility

Sex/Gender

Female

Age

25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with breast cancer including invasive or in situ carcinoma whose cancer was approved through pathological examination; Women aged 25-65 years; BMI between 25 to 35 kg/m2; not using 1000 IU daily or 50000 IU weekly or 300000 intramuscular injection of vitamin D supplement for at least 4 months before the study; not using dietary, herbal or omega-3 supplements during the intervention period; Patients were diagnosed with breast cancer at least 6 months prior the study and treatment protocols including surgery, radiotherapy and chemotherapy were completed. Exclusion criteria: History of malabsorption syndrome, calcium metabolism disorder, gastrointestinal, renal, inflammatory (sarcoidosis, etc.) and other endocrinological diseases; Treatment for weight reduction; high levels of plasma vitamin D

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Plasma vitamin D level. Timepoint: Baseline and post- intervention. Method of measurement: ELISA.	—

Secondary

Measure	Time frame
Oxidative stress biomarkers including Malondialdehyde (MDA), Total Antioxidant Capacity (TAC), Superoxide dismutase (SOD). Timepoint: Baseline and post- intervention. Method of measurement: ELISA and colorometic method.;Inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), Tumor necrosis factor alpha (TNFa), Interleukin 6 (IL-6), ß-Interferon (IFN-ß). Timepoint: Baseline and post- intervention. Method of measurement: ELISA.;Biomarkers associated with cell proliferation, differentiation, damage and apoptosis including Matrix metallopeptidase 9 (MMP-9), Plasminogen activator inhibitor-1 (PAI-1), 8-hydroxy-2'-deoxyguanosine (8-OHdG), E-cadherin, B-cell lymphoma2 (Bcl-2), Intercellular adhesion molecule 1 (ICAM-1), Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Baseline and post- intervention. Method of measurement: ELISA.;Anthropometric indicators including Weight, Height, Body Mass Index (BMI), Waist Circumferences, Hip Circumferences, Body Composition. Timepoint: Baseline and post- intervention. Method of measurement: Digital scale,stadiometer, measuring tape.;Metabolic profiles including low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (TC), triglyceride (TG), Aspartate Aminotransferase (SGOT), glutamate-pyruvate transaminase (SGPT), Urea, Creatinine. Timepoint: Baseline and post- intervention. Method of measurement: Colorometic method.	—

Measure

Time frame

Oxidative stress biomarkers including Malondialdehyde (MDA), Total Antioxidant Capacity (TAC), Superoxide dismutase (SOD). Timepoint: Baseline and post- intervention. Method of measurement: ELISA and colorometic method.;Inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), Tumor necrosis factor alpha (TNFa), Interleukin 6 (IL-6), ß-Interferon (IFN-ß). Timepoint: Baseline and post- intervention. Method of measurement: ELISA.;Biomarkers associated with cell proliferation, differentiation, damage and apoptosis including Matrix metallopeptidase 9 (MMP-9), Plasminogen activator inhibitor-1 (PAI-1), 8-hydroxy-2'-deoxyguanosine (8-OHdG), E-cadherin, B-cell lymphoma2 (Bcl-2), Intercellular adhesion molecule 1 (ICAM-1), Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Baseline and post- intervention. Method of measurement: ELISA.;Anthropometric indicators including Weight, Height, Body Mass Index (BMI), Waist Circumferences, Hip Circumferences, Body Composition. Timepoint: Baseline and post- intervention. Method of measurement: Digital scale,stadiometer, measuring tape.;Metabolic profiles including low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (TC), triglyceride (TG), Aspartate Aminotransferase (SGOT), glutamate-pyruvate transaminase (SGPT), Urea, Creatinine. Timepoint: Baseline and post- intervention. Method of measurement: Colorometic method.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Hossein Davoudi

1) Cancer Research Center, Shahid Beheshti University of Medical Sciences 2) Department of Nutrition

hdavoodi1345@gmail.com+98 21 2236 0662

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 2, 2026