Study on the Correlation of Free Vitamin d With BMD and Fracture
Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 1, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJuly 30, 2018
July 1, 2018
9 months
July 1, 2018
July 27, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Free vitamin D
measured using free vitamin D Elisa kit
! day
Total vitamin D
It is measured as a part of routine investigation at the time of admission
! day
Secondary Outcomes (2)
BMD
! day
Vertebral fracture
! day
Study Arms (2)
free vitamin d
EXPERIMENTALfree vitamin is directly measured from blood serum using an ELISA kit
total vitamin d
EXPERIMENTALTotal vitamin d is measured routinely from blood serum
Interventions
using the patient's blood serum ELISA test for free vitamin d can be performed
Eligibility Criteria
You may qualify if:
- patients with a diagnosis of osteoporosis and with or without fracture
- post- menopausal women
- age \> 48 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Limin Ronglead
Study Sites (1)
Third affiliated hospital of sun yat sen university
Guangzhou, Guangdong, 510630, China
Related Publications (1)
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.
PMID: 32164704DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kishor Chhantyal, MBBS
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor, department of spine surgery
Study Record Dates
First Submitted
July 1, 2018
First Posted
July 30, 2018
Study Start
March 1, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
July 30, 2018
Record last verified: 2018-07