High Dose Vitamin D vs Standard Dose Vitamin D Study

• Status: Terminated
• Trial end date: 2018-12-10
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mothaffar Rimawi; Polly Niravath
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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.