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

Not Applicable

• Conditions: Osteoporosis
• Interventions: Diagnostic Test: free vitamin d test; Diagnostic Test: total vitamin d

• Registration Number: NCT03605173
• Lead Sponsor: Limin Rong

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.

Study Timeline

• Study Start: 2018-03-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-27
• Last Update Submitted: 2018-07-27
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
free vitamin d	free vitamin d test	free vitamin is directly measured from blood serum using an ELISA kit
total vitamin d	total vitamin d	Total vitamin d is measured routinely from blood serum

Primary Outcome Measures

Name	Time	Method
Free vitamin D	! day	measured using free vitamin D Elisa kit
Total vitamin D	! day	It is measured as a part of routine investigation at the time of admission

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Third affiliated hospital of sun yat sen university; 🇨🇳 Guangzhou, Guangdong, China