High Dose Vitamin D vs Standard Dose Vitamin D Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01988090
Recruitment Status : Recruiting
First Posted : November 20, 2013
Last Update Posted : August 9, 2017
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

Brief Summary:
This study is being done to look at the difference, if there is a difference between two different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients. The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent aromatase inhibitor arthralgia (AIA).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: 800 IU Vitamin D Supplement Drug: 50,000 IU Vitamin D supplement Phase 2

Detailed Description:
Treatments with anti-estrogen agents for hormone receptor positive breast cancer is the most efficacious of systemic therapies, with aromatase inhibitors (AI's) being considered the most active anti-estrogen therapy in early stage breast cancer. But, use of these treatments has been shown to cause musculoskeletal (joint/muscle) side effects that sometimes cause patients to discontinue the use of them. Also, Vitamin D deficiency is a well know cause of a wide array of musculoskeletal issues. There is evidence that Vitamin D supplementation may help prevent arthralgia while on AI's. Therefore, the investigators want to see if giving a higher dose of Vitamin D could decrease the incidence of AIA as compared to a standard dose of Vitamin D. The investigators believe that this could possibly result in patients continued treatment with AI therapy for hormone receptor positive breast cancer.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: High Dose Vitamin D ARM
50,000 IU Vitamin D supplement
Drug: 50,000 IU Vitamin D supplement
High Dose

Active Comparator: 800 IU Vitamin D Supplement
800 IU Vitamin D Supplement
Drug: 800 IU Vitamin D Supplement
Standard Dose

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 52 Weeks / 5 years ]

    The primary endpoint for this study is development of Aromatase Inhibitor Arthralgia (AIA) in each arm after 12 weeks of AI therapy. We will measure this by using patient questionnaires that describe the level of AIA pain experienced by the participant. We will also measure the grip strength of the patients enrolled.

    At five years, we will compare breast cancer recurrence rates in each arm to see if there is a difference between those patients that had less pain and stayed on their aromatase inhibitor therapy.

Secondary Outcome Measures :
  1. Compliance with Anti-Cancer Treatment [ Time Frame: 52 Weeks ]

    We will check compliance of aromatase inhibitor therapy during the study by reviewing the patient's use of AI drug. This will be done by counting remaining pills in patient's bottles of AI at weeks 12, 24, 36, and 52 weeks. Compliance rate over 52 weeks of AI therapy will be compared between the two arms using longitudinal data analysis.

    We will test the participant's blood to see if there is an association between low baseline vitamin D levels and AIA (aromatase inhibitor arthralgia / pain).

Other Outcome Measures:
  1. Number of patients that have improved grip strength due to less pain [ Time Frame: 5 Years ]
    Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using logistic regression analysis and Spearman correlation at three time points throughout the study - baseline, week 12, and week 52.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • All participants must be female and at least 21 years of age
  • Signed informed consent
  • Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR).
  • Post-menopausal
  • Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks
  • Bisphosphonates are allowed at the treating investigator¡¦s discretion
  • Performance status (WHO/ECOG scale) 0-2.

Exclusion Criteria:

  • History of kidney stones
  • Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters
  • History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion
  • Baseline Vitamin D level greater than 50 ng/mL
  • Inability or unwillingness to comply with, or follow study procedures.
  • Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or orlistat
  • Malabsorption syndrome, such as Crohn's disease

Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the study medications. Patients who are on cholestyramine or orlistat will not be allowed on the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between Vitamin D and anti-epileptic medications.

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): NCT01988090

Contact: Claudette Foreman, Sr. CRC 713-798-9143
Contact: Kristen Otte, BS 713-798-8874

United States, Missouri
Washington University / Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tracy Skinner, RC    314-362-0263   
Contact: Jill Anderson    (314) 747-5209   
Principal Investigator: Foluso Ademuyiwa, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Brenda Reusser, B.A.    713-798-1929   
Sub-Investigator: Julie Nangia, MD         
Sub-Investigator: Mothaffar Rimawi, MD         
Sub-Investigator: C. Kent Osborne, MD         
Sub-Investigator: Sao Jiralerspong, M.D.         
Sub-Investigator: Matthew Ellis, M.D.         
Sponsors and Collaborators
Mothaffar Rimawi
Principal Investigator: Mothaffar Rimawi, MD Baylor College of Medicine

Responsible Party: Mothaffar Rimawi, Professor, Baylor Breast Care Center Identifier: NCT01988090     History of Changes
Other Study ID Numbers: H-33261
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
Breast Cancer
Hormone Receptor Positive
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