Overview

This trial is active, not recruiting.

Condition age-related osteoporosis
Treatment vitamin d
Sponsor University of Calgary
Collaborator Pure North S'Energy Foundation
Start date August 2013
End date December 2017
Trial size 300 participants
Trial identifier NCT01900860, 20130101

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 assessed by high resolution peripheral quantitative tomography (HR-pQCT) measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA). Other measures of bone and calcium metabolism will be assessed. The trial will last as long as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome variables assessed include quality of life, depression, muscle strength and balance.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Subjects in this arm receive 10,000 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years
vitamin d Vitamin D3, Cholecalciferol
Three different doses of vitamin D will be administered in a double-blinded fashion. The three doses are 400, 4000, or 10,000 IU/day
(Active Comparator)
Subjects in this arm receive 4,000 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years
vitamin d Vitamin D3, Cholecalciferol
Three different doses of vitamin D will be administered in a double-blinded fashion. The three doses are 400, 4000, or 10,000 IU/day
(Active Comparator)
Subjects in this arm receive 400 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years
vitamin d Vitamin D3, Cholecalciferol
Three different doses of vitamin D will be administered in a double-blinded fashion. The three doses are 400, 4000, or 10,000 IU/day

Primary Outcomes

Measure
Bone strength, as measured by Finite Element Analysis of High Resolution peripheral Quantitative Computed Tomography (HR-pQCT)
time frame: Particiants will be followed from baseline up to 36 months

Secondary Outcomes

Measure
Bone Mineral Density as measured by Dual X-ray Absorptiometry
time frame: Particiants will be followed from baseline up to 36 months
Quality of Life
time frame: Particiants will be followed from baseline up to 36 months
Depression symptoms
time frame: Particiants will be followed from baseline up to 36 months
Biochemical markers of calcium and bone metabolism
time frame: Particiants will be followed from baseline up to 36 months
Balance and grip strength
time frame: Particiants will be followed from baseline up to 36 months

Eligibility Criteria

Male or female participants from 55 years up to 70 years old.

Inclusion Criteria: - 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 Criteria: - A serum 25-[OH] vitamin D (25OHD) of <30 nmol/L (<12 ng/mL) or >100 nmol/L (40 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: 1. 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. 2. 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.

Additional Information

Official title Randomized Double-blind Study Investigating Dose-dependent Longitudinal Effects of Vitamin D Supplementation on Bone Health
Principal investigator David A Hanley, MD, FRCPC
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, leading to improved bone strength as assessed by finite element analysis. 2. It is hypothesized that vitamin D, in a dose-dependent manner, will increase bone density in the central skeleton (spine, hip), as measured by the current standard method of dual X-ray absorptiometry (DXA). 3. It is hypothesized that vitamin D, in a dose-dependent manner, will have an impact on quality of life, including indices of depression, as measured by the SF-36 questionnaire and an appropriate index of depression. Outcomes: Primary outcome: - bone strength as measured by HR-pQCT, including an assessment of the relative contribution of trabecular and cortical bone. Secondary outcomes: - bone mineral density as measured by DXA - parameters of calcium metabolism, including biochemical markers of bone turnover and DNA to examine possible variations in the genes that control vitamin D metabolism. - quality of life score - depression scale score - balance, grip strength. - fasting glucose and Hemoglobin A1C will also be measured. - Safety will be assessed during the scheduled follow-up visits by obtaining history of adverse events, as well as measurements of serum and urine parameters of mineral metabolism as described below. INTERVENTION DRUG: Vitamin D3 in one of three doses Rationale: For adults under age 70 years, the recent Institute of Medicine (IOM) report recommends a total intake of 600 IU vitamin D/day will provide all the vitamin D needed for bone health, and since the typical Canadian diet contains between 200 and 300 units of vitamin D, the subjects in the lowest dose arm of our study will receive 400 IU/day. The other two groups will receive 10,000 IU and 4,000 IU, respectively. The 10,000 IU dose is the tolerable upper intake level (TUL) recommended by Hathcock et al (Am J Clin Nutr 2007) and 4,000 IU is the IOM's recommended TUL. Calcium intake: All subjects will have adequate calcium intake as defined by the Institute of Medicine (total of 1200 mg/day). A brief dietary history will be taken and subjects will be instructed to take an appropriate dose of supplemental calcium if their daily intake is less than 1200 mg/day (the IOM's Recommended Daily Allowance for this study population). Interim analysis (with maintenance of blinding of subjects and investigators as to treatment arm): - planned at and of years 1 and 2, as well as the final analysis at year 3.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Calgary.