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

  • STATUS
    Recruiting
  • End date
    Dec 12, 2024
  • participants needed
    128
  • sponsor
    Wake Forest University Health Sciences
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Updated on 12 May 2022
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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
SponsorWake Forest University Health Sciences
Last Modified on12 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to participate in this
Written informed consent and HIPAA authorization for release of personal health
study
information. NOTE: HIPAA authorization may be included in the informed consent or
Age; 45 years at the time of consent
obtained separately
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
Baseline 25(OH)D level <10ng/mL or >80ng/mL
Baseline serum corrected calcium level of >10.3mg/dL
Uncontrolled intercurrent illness/medical condition or psychiatric illness/social
Breast cancer with distant metastasis
situations that would limit compliance with study requirements as determined by the
History of previous breast cancer
Investigator
Patients will undergo breast surgery and/or radiotherapy alone without planned
Pregnancy or lactation
neoadjuvant and/or adjuvant anti-cancer drug therapy
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
Bone mineral density less than the expected range for age on baseline DEXA scan
Concurrent treatment for thyroid deficiency
(defined as Z-score </= -2.0)
BMI <18.5
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)
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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