Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2013-10-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin D3
Vitamin D3 40,000 iu per day by mouth
Vitamin D3
Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.
Placebo
Placebo taken daily by mouth
Placebo
Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.
Interventions
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Vitamin D3
Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.
Placebo
Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. Clinically palpable tumour(s) (greater than or equal to 2 cm)
4. Normal serum and urine calcium and serum PTH values at baseline (as defined by Ottawa Hospital)
5. Written informed consent for study
Exclusion Criteria
2. History of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment
3. ECOG performance Status \> 2
4. Hypercalciuria on initial baseline urine, defined as Ca/Creatinine Ratio\> 1.0
5. Current or previous history of urolithiasis or hyperparathyroidism
6. Abnormal hepatic function according to Ottawa Hospital norms (Total Bilirubin \>2x upper limit of normal, ALT/AST \>3x upper limit of normal)and/or abnormal renal function (Creatinine \> 150 µmol/L)
7. History of granulomatous disease such as tuberculosis or sarcoidosis.
8. Intake of Vitamin D (cholecalciferol) supplement ≥ 2000 IU/day within the last 2 months
9. Inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).
18 Years
FEMALE
No
Sponsors
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Canadian Breast Cancer Foundation
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Angel Arnaout, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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The Ottawa Hospital Woman's Breast Health Centre
Ottawa, Ontario, Canada
Countries
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References
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Arnaout A, Robertson S, Pond GR, Vieth R, Jeong A, Hilton J, Ramsey T, Clemons M. Randomized window of opportunity trial evaluating high-dose vitamin D in breast cancer patients. Breast Cancer Res Treat. 2019 Nov;178(2):347-356. doi: 10.1007/s10549-019-05392-9. Epub 2019 Aug 9.
Other Identifiers
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20120362-2OH
Identifier Type: -
Identifier Source: org_study_id
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