High Dose Vitamin D vs Standard Dose Vitamin D Study
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|ClinicalTrials.gov Identifier: NCT01988090|
Recruitment Status : Terminated (An interim analysis demonstrated no benefit of high dose vitamin D when compared to standard dose vitamin D in the reduction or prevention of arthralgia)
First Posted : November 20, 2013
Results First Posted : March 19, 2019
Last Update Posted : August 9, 2021
|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)|
|Actual Enrollment :||93 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|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 21, 2018|
|Actual Study Completion Date :||December 10, 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
- Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy [ Time Frame: 12 weeks ]Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.
- Compliance With Anti-Cancer Treatment [ Time Frame: 52 Weeks ]We checked 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 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated.
- Association Between Vitamin D Levels Changes and Treatment. [ Time Frame: 12 weeks ]Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.
- Grip Strength [ Time Frame: 52 weeks ]Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using 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
|United States, Missouri|
|Washington University / Siteman Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mothaffar Rimawi, MD||Baylor College of Medicine|