Status:
COMPLETED
Dose-dependent Effects of Vitamin D on Bone Health
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Pure North S'Energy Foundation
Conditions:
Age-Related Osteoporosis
Eligibility:
All Genders
55-70 years
Phase:
NA
Brief Summary
We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000, and 10,000 International Units (IU) per day, to assess the effect on bone density and architecture as asse...
Detailed Description
Hypotheses being tested: 1. It is hypothesized that vitamin D, in a dose-dependent manner, will suppress parathyroid hormone action, resulting in less bone turnover, and decreased cortical porosity, ...
Eligibility Criteria
Inclusion
- Healthy women and men between 55 and 70 years of age; women will be at least 5 years post-menopause. Presence of a chronic illness does not exclude participation if the condition is stable and managed by a physician.
- Baseline lumbar spine and total hip bone mineral density (BMD) T-score above 2.5 as assessed using dual x-ray absorptiometry (DXA).
Exclusion
- A serum 25-\[OH\] vitamin D (25OHD) of \<30 nmol/L (\<12 ng/mL) or \>125 nmol/L (50 ng/mL).
- Hypercalcemia (serum calcium \>2.55 mmol/L), hypocalcemia (serum calcium \<2.10 mmol/L) or eGFR \<30 mL/min.
- Surgical cure of Primary Hyperparathyroidism within the last year.
- Active kidney stone disease (recurrent stones, recent kidney stone \[within last 2 years\])
- Known hypersensitivity or allergy to Vitamin D
- Serum creatinine, AST, ALT, PTH, calcium, or alkaline phosphatase greater than 1.5 times the upper limit of normal at the screening visit
- BMD exclusions:
- High 10-year risk for osteoporotic fracture, as defined by the Canadian Association of Radiologists/Osteoporosis Canada calculator, or the World Health Organization's FRAX calculator.
- DXA T-score below or equal to -2.5 SD.
- Have taken bone active osteoporosis prescription drugs in the past 2 years (bisphosphonates) or 1 year (other osteoporosis prescription therapies).
- Any medical condition that would prevent participation in a clinical trial for a full three years.
- Medications such as prednisone \>2.5 mg daily (or equivalent); other bone active medications such as tamoxifen or aromatase inhibitors for breast cancer, or androgen deprivation therapy of prostate cancer.
- Disorders known to affect vitamin D metabolism such as sarcoidosis or renal failure or malabsorption disorders (e.g. pancreatic insufficiency or celiac disease).
- Regular (monthly or more frequent) use of tanning salons.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01900860
Start Date
August 1 2013
End Date
December 31 2017
Last Update
April 17 2019
Active Locations (1)
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1
The University of Calgary
Calgary, Alberta, Canada, T2N 4Z6