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

NCT03605173 — Not applicable, Unknown, 125 participants, Limin Rong
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Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?

RegistryNCT03605173
StatusUnknown
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: single, diagnostic
Enrollment125 (Estimated)
SponsorLimin Rong (Other)
ConditionsOsteoporosis
Interventionsfree vitamin d test, total vitamin d (Diagnostic test)
Datesstart 2018-03-01, primary completion 2018-11-30 (estimated), completion 2018-11-30 (estimated), first posted 2018-07-30, last updated 2018-07-30
Locations1 site in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
free vitamin dExperimentalDiagnostic Test: free vitamin d testfree vitamin is directly measured from blood serum using an ELISA kit
total vitamin dExperimentalDiagnostic Test: total vitamin dTotal vitamin d is measured routinely from blood serum
  • free vitamin d test (Diagnostic test): using the patient's blood serum ELISA test for free vitamin d can be performed
  • total vitamin d (Diagnostic test): routinely measured from serum

+Outcome measures

Primary outcomes

  • 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 outcomes

  • BMD [! day]: Bone mineral density is measured using the Dual-energy X-ray absorptiometry
  • Vertebral fracture [! day]: With the help of plain X-ray

+Eligibility

Sex: All, ages: 48 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Third affiliated hospital of sun yat sen universityGuangzhou, GuangdongChinaRecruiting

+Publications

  • Results publication: Chhantyal K, He L, Mo J, Yin M, He T, Chen Y, Yang Y, Zhang L, Rong L. Free vitamin D correlate better with bone mineral density and thoracolumbar junction osteoporotic vertebral fractures than serum vitamin D. BMC Musculoskelet Disord. 2020 Mar 12;21(1):164. doi: 10.1186/s12891-020-3179-7. PMID 32164704

+Investigators

My Notes