Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01900860
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2013-07-02
Brief Title:
Dose-dependent Effects of Vitamin D on Bone Health
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Randomized Double-blind Study Investigating Dose-dependent Longitudinal Effects of Vitamin D Supplementation on Bone Health
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose to conduct a randomized double blind trial of three doses of vitamin D 400 4000 and 10000 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
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 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 outcomes
1 bone density and 2 strength as measured by HR-pQCT
Secondary outcomes
HR-pQCT assessment of bone microarchitecture examining the relative contribution of trabecular and cortical bone We have chosen four parameters for statistical analysis and have listed them as secondary outcome variables in the section below cortical density cortical porosity trabecular density and trabecular number
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 Dday 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 IUday The other two groups will receive 10000 IU and 4000 IU respectively The 10000 IU dose is the tolerable upper intake level TUL recommended by Hathcock et al Am J Clin Nutr 2007 and 4000 IU is the IOMs recommended TUL
Calcium intake
All subjects will have adequate calcium intake as defined by the Institute of Medicine total of 1200 mgday 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 mgday the IOMs 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
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 outcomes
1 bone density and 2 strength as measured by HR-pQCT
Secondary outcomes
HR-pQCT assessment of bone microarchitecture examining the relative contribution of trabecular and cortical bone We have chosen four parameters for statistical analysis and have listed them as secondary outcome variables in the section below cortical density cortical porosity trabecular density and trabecular number
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 Dday 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 IUday The other two groups will receive 10000 IU and 4000 IU respectively The 10000 IU dose is the tolerable upper intake level TUL recommended by Hathcock et al Am J Clin Nutr 2007 and 4000 IU is the IOMs recommended TUL
Calcium intake
All subjects will have adequate calcium intake as defined by the Institute of Medicine total of 1200 mgday 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 mgday the IOMs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None