Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926315

Enrollment

Registered

2009-06-23

Start date

2007-07-31

Completion date

2013-12-31

Last updated

2012-11-01

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

Conditions

Breast Neoplasms, Postmenopausal Disorder

Keywords

Breast Neoplasms, Calcitriol, Postmenopausal, Cell Proliferation, Gene Expression Profiling

Brief summary

The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.

Detailed description

Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts. Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.

Interventions

DRUGcalcitriol

Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.

DRUGCalcitriol

calcitriol 0.25 mcg PO bid

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Postmenopausal women * Invasive breast carcinoma * Clinical conditions for breast surgery * No previous neoadjuvant treatment for breast cancer * Agreement to take part in the study and sign the informed consent

Exclusion criteria

* History of hypercalcemia or nephrolithiasis * Current use of corticosteroids, vitamin D supplementation, HRT * Previous chemotherapy, hormonotherapy or radiotherapy * Parathyroid disease * Absence of clinical condition to receive supplementation

Design outcomes

Primary

Measure	Time frame
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile	30 days

Secondary

Measure	Time frame
Follow-up for 5 years	5 years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026