A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation (NCT05016310) | Clinical Trial Compass
CompletedNot Applicable
A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation
United States7 participantsStarted 2021-09-16
Plain-language summary
This is a randomized study evaluating the effects of early intensive vitamin D supplementation compared to standard of care vitamin D supplementation on bone health over an 18 month period.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
✓. Age; 45 years at the time of consent
✓. Female
✓. Histological or cytological confirmation of breast cancer clinical or pathologic stages 0-III
✓. Patient has been recommended to initiate systemic therapy for breast cancer. It is preferable for patient to enroll prior to systemic therapy initiation. However, enrollment will be allowed if systemic therapy has been initiated within 4 weeks prior to enrollment (randomization).
✓. Systemic therapy for breast cancer is planned
✓. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
✓. Previous vitamin D supplementation allowed, as long as patient is agreeable to stop previous dosing at the time of trial enrollment, to comply with trial procedures including a baseline 25(OH)D level, and is otherwise determined to be appropriate for enrollment
Exclusion criteria
✕. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the Investigator
✕. Patients will undergo breast surgery and/or radiotherapy alone without planned neoadjuvant and/or adjuvant anti-cancer drug therapy.
What they're measuring
1
Percent change from baseline in bone mineral density (g/cm^2) from baseline to the Year 1 DEXA scan
Timeframe: 15 months (12 plus a +3 month calendar window)
✕. Baseline 25(OH)D level \<10ng/mL or \>80ng/mL
✕. Baseline serum corrected calcium level of \>10.3mg/dL
✕. Bone mineral density less than the expected range for age on baseline DEXA scan (defined as Z-score \</= -2.0)
✕. Breast cancer with distant metastasis
✕. History of previous breast cancer
✕. Postmenopausal, as confirmed by the lack of menses \>/=12 months and/or ovarian function laboratories (estradiol, FSH) consistent with menopause (if any of two values outside of menopausal range and subject had menses within 12 months, subject would be considered perimenopausal or premenopausal and therefore eligible for enrollment)