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Dose-dependent Effects of Vitamin D on Bone Health

NCT01900860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2019-04-17

No results posted yet for this study

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.

Conditions

  • Age-Related Osteoporosis

Interventions

DIETARY_SUPPLEMENT

Vitamin D

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

Sponsors & Collaborators

  • Pure North S'Energy Foundation

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • David A Hanley, MD, FRCPC · The University of Calgary

  • Steven K Boyd, PhD · The University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-12-07
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900860 on ClinicalTrials.gov