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.|
|ClinicalTrials.gov Identifier: NCT01988090|
Recruitment Status : Recruiting
First Posted : November 20, 2013
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: 800 IU Vitamin D Supplement Drug: 50,000 IU Vitamin D supplement||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: High Dose Vitamin D ARM
50,000 IU Vitamin D supplement
Drug: 50,000 IU Vitamin D supplement
Active Comparator: 800 IU Vitamin D Supplement
800 IU Vitamin D Supplement
Drug: 800 IU Vitamin D Supplement
- 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.
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01988090
|Contact: Claudette Foreman, Sr. CRCfirstname.lastname@example.org|
|Contact: Kristen Otte, BSemail@example.com|
|United States, Missouri|
|Washington University / Siteman Cancer Center||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Tracy Skinner, RC 314-362-0263 firstname.lastname@example.org|
|Contact: Jill Anderson (314) 747-5209 email@example.com|
|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 firstname.lastname@example.org|
|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.|
|Principal Investigator:||Mothaffar Rimawi, MD||Baylor College of Medicine|