High Dose Vitamin D vs Standard Dose Vitamin D Study

NCT01988090 | Terminated Phase 2 Results

• 1 other identifier: H-33261
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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).

Conditions

Breast Cancer

Keywords

Breast Cancer; Hormone Receptor Positive; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy

  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.

  12 weeks

Secondary Outcomes (2)

• Compliance With Anti-Cancer Treatment

  52 Weeks

• Association Between Vitamin D Levels Changes and Treatment.

  12 weeks

Other Outcomes (1)

• Grip Strength

  52 weeks

Study Arms (2)

High Dose Vitamin D ARM

EXPERIMENTAL

50,000 IU Vitamin D supplement

Drug: 50,000 IU Vitamin D supplement

800 IU Vitamin D Supplement

ACTIVE COMPARATOR

800 IU Vitamin D Supplement

Drug: 800 IU Vitamin D Supplement

Interventions

800 IU Vitamin D Supplement DRUG

Standard Dose

800 IU Vitamin D Supplement

50,000 IU Vitamin D supplement DRUG

High Dose

High Dose Vitamin D ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mothaffar Rimawi: lead

Study Sites (2)

Washington University / Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Tao Wang
• Organization: Baylor College of Medicine

taow@bcm.edu

7137985388

Study Officials

• Mothaffar Rimawi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: July 21, 2018
• Study Completion: December 10, 2018
• Last Updated: August 9, 2021
• Results First Posted: March 19, 2019

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)