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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472445
Recruitment Status : Terminated (Slow accrual)
First Posted : November 16, 2011
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):
Melinda Telli, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Vitamin D3 Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Vitamin D and Breast Cancer: Does Weight Make a Difference?
Study Start Date : November 2011
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vitamin D3, Supportive care, A
Vitamin D 10,000 IU/day
Drug: Vitamin D3
Vitamin D 10,000 IU/day
Other Name: cholecalciferol

Experimental: Vitamin D3, Supportive Care, B
Vitamin D 400 IU/day
Drug: Vitamin D3
Vitamin D 400 IU/day
Other Name: cholecalciferol

Primary Outcome Measures :
  1. Measurement of gene expression at the mRNA (Messenger Ribonucleic acid) level using PCR (polymerase chain reaction) arrays [ Time Frame: 30 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472445

United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Melinda Telli
Principal Investigator: Melinda Telli, MD Stanford University

Responsible Party: Melinda Telli, Assistant Professor of Medicine, Stanford University Identifier: NCT01472445     History of Changes
Other Study ID Numbers: BRSADJ0024
SU-09262011-8486 ( Other Identifier: Stanford University )
21034 ( Other Identifier: Stanford IRB )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Melinda Telli, Stanford University:
Vitamin D

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents