A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation

  • STATUS
    Recruiting
  • End date
    Dec 27, 2024
  • participants needed
    128
  • sponsor
    Arielle Heeke
Updated on 27 September 2021

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.

Description

This is a randomized, open-label study designed to evaluate the effect of high dose vitamin D versus standard of care vitamin D supplementation on bone health and arthralgias. The randomization will be stratified by hormone receptor status (positive versus negative). The primary objective is to compare the effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2), in young women with non-metastatic breast cancer who receive systemic therapy.

Details
Condition Breast
Treatment High Dose Vitamin D, Standard of Care Vitamin D
Clinical Study IdentifierNCT05016310
SponsorArielle Heeke
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to
participate in this
study
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)
Note: Patients who undergo only surgery and/or radiotherapy alone would not
qualify for the study
\. 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

Subjects meeting any of the criteria below may not participate in the study
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
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)
Pregnancy or lactation
History of bone disease, including Paget's bone disease or osteomalacia
Concurrent rheumatoid or other inflammatory arthritis
Concurrent or prior treatment with bisphosphonates
Use of oral corticosteroids within the last 30 days prior to randomization
Concurrent treatment for thyroid deficiency
BMI <18.5
Currently receiving treatment for tuberculosis, or planning to receive treatment for tuberculosis during breast cancer treatments
History of another primary cancer that required systemic treatment within the last 5 years
Any of the following kidney diseases at the time of randomization: active chronic kidney disease >/= stage 3, history of kidney stones, sarcoidosis
Gastrointestinal disease that would limit the absorption of pill therapy (i.e. celiac disease, gastric bypass surgery)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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