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Vitamin D and Breast Cancer: Does Weight Make a Difference?

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Melinda Telli, Stanford University
ClinicalTrials.gov Identifier:
NCT01472445
First received: November 11, 2011
Last updated: July 22, 2014
Last verified: July 2014

November 11, 2011
July 22, 2014
November 2011
November 2014   (final data collection date for primary outcome measure)
Measurement of gene expression at the mRNA (Messenger Ribonucleic acid) level using PCR (polymerase chain reaction) arrays [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472445 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Vitamin D and Breast Cancer: Does Weight Make a Difference?
Vitamin D and Breast Cancer: Does Weight Make a Difference?

This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.

This protocol is a randomized, controlled and blinded clinical trial in obese and non-obese subjects diagnosed with breast cancer in whom we will test the effects of vitamin D supplementation in the neoadjuvant setting and evaluate changes in biomarker expression in blood and tissue comparing core breast biopsy to definitive surgical samples. Our goal is to determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by favorable changes in the gene expression patterns in the pathologic specimens as well as in serum biomarkers of insulin resistance and adipokine secretion. We expect that vitamin D administration will improve the breast cancer gene expression pattern from a high-risk configuration to a low-risk profile in the obese patients and will also cause improvement in the non-obese.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Breast Cancer
  • Drug: Vitamin D3
    Vitamin D 10,000 IU/day
    Other Name: cholecalciferol
  • Drug: Vitamin D3
    Vitamin D 400 IU/day
    Other Name: cholecalciferol
  • Experimental: Vitamin D3, Supportive care, A
    Vitamin D 10,000 IU/day
    Intervention: Drug: Vitamin D3
  • Experimental: Vitamin D3, Supportive Care, B
    Vitamin D 400 IU/day
    Intervention: Drug: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 3.1.1 Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
  • 3.1.2 No prior therapy for breast cancer.
  • 3.1.4 Age 18 years or older.
  • 3.1.5 Any menopausal status
  • 3.1.6 Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
  • 3.1.7 Availability of tissue blocks from initial core needle biopsy.
  • 3.1.8 Signed informed consent.
  • 3.1.9 Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study.

Exclusion Criteria:

  • 3.2.1 Presence of any Metastatic lesion.
  • 3.2.2 History of parathyroid disease, hypercalcemia, or kidney stones.
  • 3.2.3 History of SERM or aromatase inhibitor therapy.
  • 3.2.4 Taking metformin.
  • 3.2.5 History of renal failure requiring dialysis or kidney transplantation.
  • 3.2.6 Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
  • 3.2.7 Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention
  • 3.2.9 Any condition potentially interfering with subjects ability to comply with taking study medication.
  • 3.2.10 Any medical condition that would potentially interfere with vitamin D absorption.
  • 3.2.11 Current participation in another research study that would increase risk to subject, in the opinion of the investigators.
  • 3.2.12 Patients currently taking more than 2000 IU of Vitamin D.
Female
18 Years and older
No
United States
 
NCT01472445
BRSADJ0024, SU-09262011-8486, 21034, 21034
Yes
Melinda Telli, Stanford University
Melinda Telli
Not Provided
Principal Investigator: Melinda Telli, MD Stanford University
Stanford University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP