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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03605173
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Information provided by (Responsible Party):
Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Diagnostic Test: free vitamin d test Diagnostic Test: total vitamin d Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Vitamin D
Drug Information available for: Vitamin D

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

Primary Outcome Measures :
  1. Free vitamin D [ Time Frame: ! day ]
    measured using free vitamin D Elisa kit

  2. Total vitamin D [ Time Frame: ! day ]
    It is measured as a part of routine investigation at the time of admission

Secondary Outcome Measures :
  1. BMD [ Time Frame: ! day ]
    Bone mineral density is measured using the Dual-energy X-ray absorptiometry

  2. Vertebral fracture [ Time Frame: ! day ]
    With the help of plain X-ray

Information from the National Library of Medicine

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Ages Eligible for Study:   48 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03605173

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Contact: Li Min Rong, MD 862085252900

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China, Guangdong
Third affiliated hospital of sun yat sen university Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Li Min RONG, MD    862085252900   
Sponsors and Collaborators
Limin Rong
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Principal Investigator: Kishor Chhantyal, MBBS Third affiliated hospital of sun yat sen university

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Responsible Party: Limin Rong, professor, department of spine surgery, Third Affiliated Hospital, Sun Yat-Sen University Identifier: NCT03605173     History of Changes
Other Study ID Numbers: free vitamin d - bmd
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents