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

July 27, 2018 updated by: Limin Rong

Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third affiliated hospital of sun yat sen university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: free vitamin d
free vitamin is directly measured from blood serum using an ELISA kit
Diagnostic test: free vitamin d test
using the patient's blood serum ELISA test for free vitamin d can be performed
Experimental: total vitamin d
Total vitamin d is measured routinely from blood serum
Diagnostic test: total vitamin d
routinely measured from serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free vitamin D
Time Frame: ! day
measured using free vitamin D Elisa kit
! day
Total vitamin D
Time Frame: ! day
It is measured as a part of routine investigation at the time of admission
! day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limin Rong

Investigators

  • Principal Investigator: Kishor Chhantyal, MBBS, Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

November 30, 2018

Study Registration Dates

First Submitted

July 1, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • free vitamin d - bmd

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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