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

Limin Rong

Status: Unknown

Conditions: Osteoporosis

Treatments: Diagnostic Test: total vitamin d; Diagnostic Test: free vitamin d test

Study type: Interventional

Funder types: Other

Identifiers

NCT03605173

free vitamin d - bmd

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 48+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

free vitamin d

Experimental group

Description:

free vitamin is directly measured from blood serum using an ELISA kit

Treatment:

Diagnostic Test: free vitamin d test

total vitamin d

Experimental group

Description:

Total vitamin d is measured routinely from blood serum

Treatment:

Diagnostic Test: total vitamin d