Upstate Active Clinical Trials Seeking Participants
Study title
Vitamin D and Breast Cancer Biomarkers
IRB number
239074
What is the purpose of the study?
Dr. Jayne Charlamb at SUNY Upstate Medical University is looking to enroll premenopausal women under the age of 55 into a research study to determine if taking Vitamin D for one year will decrease breast density. Younger woman typically have dense breast which is normal. On a mammogram breast density will show up as a white area, a breast cancer will also show up as a white area, this makes it difficult to detect breast cancer in women with dense breast.
The main goal of this study is to see whether treating women with vitamin D supplements will reduce breast density seen on a mammogram. The breast is composed of fat, milk glands and various other tissues, which determine how dense the breasts are. High breast density has been shown to be a strong risk factor for developing breast cancer. It is thought that decreasing breast density may decrease the risk for breast cancer.
The study will also compare the effects (good and bad) of taking vitamin D supplements every day for 1 year with those of taking placebo every day for 1 year on several biomarkers of breast cancer risk. We are testing the effects of vitamin D on these biomarkers because some research studies show that vitamin D may protect against breast cancer.
About 250 women will take part in this study. Women will take either Vitamin D 2000 IU or placebo for a year. Neither the woman nor the doctor will know if she is taking the Vitamin D or placebo.
Who is eligible?
In order to qualify for the study women must: be 55 years of age or younger be premenopausal with regular cycles (at least four cycles in the last six months), have a breast density greater than 25% as determined by entry mammogram, and have a normal calcium level which will be determined by the enrollment blood work. You are not eligible for this study if: you have a history of breast cancer or ovarian cancer, you have a diagnosis of osteoporosis, you have a history of kidney stones, you have a history of hyperparathyroid disease or other disturbances of calcium metabolism requiring intervention, you have breast implants or have had breast reduction surgery, and if you are currently taking more than 400 IU of Vitamin D (women who are on more than 400 IU can stop the vitamin for six months and then join the study). If you are a woman of childbearing potential, you should not be pregnant and not plan on becoming pregnant because pregnancy can affect breast density. You should use a method of birth control throughout your participation in the trial. If you are interested in this trial, please contact the study coordinator by email or investigator noted below.
What is involved if I participate?
- How long is the study?
Duration: 1 year - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
1. Entry and 12 month mammogram 2. Entry and 12 month blood work 3. Entry and 12 month physical exam 4. Entry and 12 month: complete study questionnaires
Who is the doctor administering the study?
Jayne Charlamb MD
Where will the study take place?
UHCC (University Health Care Center) 90 Presidential Plaza, Syracuse, NY 13202
Over what time period is the study scheduled to run?
3/15/2011 to 3/15/2013
Who can I contact for more information?
- Name: Linda Ellinwood
- Phone: 315-464-1852
- Email: ellinwol@upstate.edu
- Fax: 315-464-2177
If you are interested in this trial, please contact the study coordinator or investigator noted above.
