Back to resultsStudy on the Correlation of Free Vitamin d With BMD and Fracture
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
free vitamin d test
total vitamin d
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- patients with a diagnosis of osteoporosis and with or without fracture
- post- menopausal women
- age > 48 years
Exclusion Criteria:
- vitamin D supplementation in recent 6 months
- patients on steroid
- age < 48 years
- patients with chronic diseases such as liver cirrhosis, renal failure, hypertension, hyperparathyroidism
Sites / Locations
- Third affiliated hospital of sun yat sen universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
free vitamin d
total vitamin d
Arm Description
free vitamin is directly measured from blood serum using an ELISA kit
Total vitamin d is measured routinely from blood serum
Outcomes
Primary Outcome Measures
Free vitamin D
measured using free vitamin D Elisa kit
Total vitamin D
It is measured as a part of routine investigation at the time of admission
Secondary Outcome Measures
BMD
Bone mineral density is measured using the Dual-energy X-ray absorptiometry
Vertebral fracture
With the help of plain X-ray
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03605173
Brief Title
Study on the Correlation of Free Vitamin d With BMD and Fracture
Official Title
Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Limin Rong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D.
Detailed Description
Osteoporosis is a major health issue worldwide as it increases the risk of fragility fracture and chronic disability. The studies on the association between vitamin d and osteoporosis have yielded conflicting results. While some have shown a positive correlation, others have concluded that there is no association at all. Recent reports have shown vitamin D supplementation do not prevent fragile fractures. This might be because the actual vitamin D status, which should be the free vitamin D, has not been measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
free vitamin d
Arm Type
Experimental
Arm Description
free vitamin is directly measured from blood serum using an ELISA kit
Arm Title
total vitamin d
Arm Type
Experimental
Arm Description
Total vitamin d is measured routinely from blood serum
Intervention Type
Diagnostic Test
Intervention Name(s)
free vitamin d test
Intervention Description
using the patient's blood serum ELISA test for free vitamin d can be performed
Intervention Type
Diagnostic Test
Intervention Name(s)
total vitamin d
Intervention Description
routinely measured from serum
Primary Outcome Measure Information:
Title
Free vitamin D
Description
measured using free vitamin D Elisa kit
Time Frame
! day
Title
Total vitamin D
Description
It is measured as a part of routine investigation at the time of admission
Time Frame
! day
Secondary Outcome Measure Information:
Title
BMD
Description
Bone mineral density is measured using the Dual-energy X-ray absorptiometry
Time Frame
! day
Title
Vertebral fracture
Description
With the help of plain X-ray
Time Frame
! day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with a diagnosis of osteoporosis and with or without fracture
post- menopausal women
age > 48 years
Exclusion Criteria:
vitamin D supplementation in recent 6 months
patients on steroid
age < 48 years
patients with chronic diseases such as liver cirrhosis, renal failure, hypertension, hyperparathyroidism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Min Rong, MD
Phone
862085252900
Email
ronglimin@21cn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishor Chhantyal, MBBS
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third affiliated hospital of sun yat sen university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Min RONG, MD
Phone
862085252900
Email
ronglimin@21cn.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32164704
Citation
Chhantyal K, He L, Mo J, Yin M, He T, Chen Y, Yang Y, Zhang L, Rong L. Free vitamin D correlate better with bone mineral density and thoracolumbar junction osteoporotic vertebral fractures than serum vitamin D. BMC Musculoskelet Disord. 2020 Mar 12;21(1):164. doi: 10.1186/s12891-020-3179-7.
Results Reference
derived
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Study on the Correlation of Free Vitamin d With BMD and Fracture
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