Vitamin D and Physical Activity on Bone Health
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ClinicalTrials.gov Identifier: NCT01419730 |
Recruitment Status
:
Recruiting
First Posted
: August 18, 2011
Last Update Posted
: October 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bone Metabolism Biomarkers Bone Mineral Density Physical Fitness | Drug: Vitamin D3 Behavioral: Physical Activity | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy |
Actual Study Start Date : | August 2011 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin D3 50,000 IU
Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks.
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Drug: Vitamin D3
Vitamin D3 50,000 IU
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Active Comparator: Vitamin D3 50,000 IU and Physical Activity
Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.
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Drug: Vitamin D3
Vitamin D3 50,000 IU
Behavioral: Physical Activity
Progressive walking and resistance band exercise prescription for a period of 24 weeks
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No Intervention: Control
Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.
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- Measure the amount of bone loss in non-metastatic breast cancer patients receiving a high dose vitamin D therapy along with a structured home-based walking and progressive resistance exercise program. [ Time Frame: 24 weeks ]
To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone metabolism biomarkers in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months.
To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months.
- Measure the effect of vitamin D and exercise on physical fitness in non-metastatic breast cancer patients [ Time Frame: 24 weeks ]Measuring physical fitness includes balance, aerobic capacity, and muscle strength in non-metastatic breast cancer patients who begin hormonal therapy within the previous 12 months.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be female and have a primary diagnosis of Stage I, II, or III hormone-receptor positive breast cancer.
- Women must be postmenopausal at time of enrollment.
- Must provide informed consent.
- Must be willing to discontinue use of calcium and/or vitamin D supplements.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.6 mg/dl.
- Participants must be slightly vitamin D deficient (serum vitamin D level <32ng/ml)
- Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.132
- Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 24-week supplementation of vitamin D.
- Must be less than five years from the diagnosis of breast cancer and must be within 12 months of starting treatment with aromatase inhibitors (AI) in accordance with American Society of Clinical Oncology (ASCO) guidelines.
Exclusion Criteria:
- Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.
- Patients who had a myocardial infarction within the past year.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
- Patients with hypercalcemia (corrected serum Ca ≥ 10.6 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
- Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.
- Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
- Patients with a known sensitivity to vitamin D.
- Patients who are severely vitamin D deficient (<10 ng/ml).
- Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
- Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.
- Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419730
Contact: Jennifer Reschke, MS | 585-275-0690 | jennifer_reschke@urmc.rochester.edu |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Principal Investigator: Luke J. Peppone, PhD, MPH |
Principal Investigator: | Luke J Peppone, PhD, MPH | University of Rochester |
Responsible Party: | Luke Peppone, Assistant Professor, University of Rochester |
ClinicalTrials.gov Identifier: | NCT01419730 History of Changes |
Other Study ID Numbers: |
34834 |
First Posted: | August 18, 2011 Key Record Dates |
Last Update Posted: | October 6, 2017 |
Last Verified: | October 2017 |
Additional relevant MeSH terms:
Vitamins Vitamin D Ergocalciferols Cholecalciferol |
Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |