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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03605173

Enrollment

125

Registered

2018-07-30

Start date

2018-03-01

Completion date

2018-11-30

Last updated

2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DIAGNOSTIC_TESTfree vitamin d test

using the patient's blood serum ELISA test for free vitamin d can be performed

DIAGNOSTIC_TESTtotal vitamin d

routinely measured from serum

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

48 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactLi Min Rong, MD

ronglimin@21cn.com862085252900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026