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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605173
• Other study ID #: free vitamin d - bmd
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: July 2018
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Li Min Rong, MD
• Phone: 862085252900
• Email: ronglimin[@]21cn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Diagnostic Test:
• free vitamin d test
using the patient's blood serum ELISA test for free vitamin d can be performed
• total vitamin d
routinely measured from serum

Locations

Country	Name	City	State
China	Third affiliated hospital of sun yat sen university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Limin Rong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free vitamin D	measured using free vitamin D Elisa kit	! day
Primary	Total vitamin D	It is measured as a part of routine investigation at the time of admission	! day
Secondary	BMD	Bone mineral density is measured using the Dual-energy X-ray absorptiometry	! day
Secondary	Vertebral fracture	With the help of plain X-ray	! day