Study on the Correlation of Free Vitamin d With BMD and F... | NCT03605173

Studies
Study on the Correlation of Free Vitamin d With BMD and Fracture

NCT03605173

Sponsor

Limin Rong

Status

Unknown status

Last Update Posted

Jul 30, 2018Actual

Enrollment

125Estimated

Phase

Not Applicable

Conditions

Osteoporosis

Interventions

free vitamin d test
total vitamin d

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Nov 30, 2018Estimated

Completion Date

Nov 30, 2018Estimated

First Submitted Date

Jul 1, 2018

First Submission Date that Met QC Criteria

Jul 27, 2018

First Posted Date

Jul 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2018

Last Update Posted Date

Jul 30, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Limin Rong, professor, department of spine surgery, Third Affiliated Hospital, Sun Yat-Sen UniversitySponsor-Investigator

Lead Sponsor

Limin RongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
free vitamin d	Experimental	free vitamin is directly measured from blood serum using an ELISA kit	Diagnostic Test: free vitamin d test
total vitamin d	Experimental	Total vitamin d is measured routinely from blood serum	Diagnostic Test: total vitamin d

Interventions

Name	Type	Description	Arm Group Labels	Other Names
free vitamin d test	Diagnostic Test	using the patient's blood serum ELISA test for free vitamin d can be performed	free vitamin d

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
BMD	Bone mineral density is measured using the Dual-energy X-ray absorptiometry	! day
Vertebral fracture	With the help of plain X-ray

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

48 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Min Rong, MD	Contact	862085252900		ronglimin@21cn.com

Overall Officials

Name	Affiliation	Role
Kishor Chhantyal, MBBS	Third Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Third affiliated hospital of sun yat sen university	Recruiting	Guangzhou	Guangdong	510630	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32164704	Derived	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.

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases