OsteoporosisNCT03605173
Study on the Correlation of Free Vitamin d With BMD and Fracture
A study testing free vitamin d test and total vitamin d in people with Osteoporosis, run by Limin Rong at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 48 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- free vitamin d test and total vitamin d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a diagnosis of osteoporosis and with or without fracture
- post- menopausal women
- age > 48 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third affiliated hospital of sun yat sen university
Guangzhou, Guangdong, 510630
Li Min RONG, MD, 862085252900, ronglimin@21cn.com
About this study
Official title: Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- free vitamin d test, total vitamin d
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free vitamin d testDiagnostic test
using the patient's blood serum ELISA test for free vitamin d can be performed
total vitamin dDiagnostic test
routinely measured from serum
| Study group | Role | What they receive |
|---|---|---|
| free vitamin d | Experimental | free vitamin is directly measured from blood serum using an ELISA kit Receives: Diagnostic Test: free vitamin d test |
| total vitamin d | Experimental | Total vitamin d is measured routinely from blood serum Receives: Diagnostic Test: total vitamin d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free vitamin D
measured using free vitamin D Elisa kit
Measured: ! day
Total vitamin D
It is measured as a part of routine investigation at the time of admission
Measured: ! day
Secondary outcomes (2)
BMD
Bone mineral density is measured using the Dual-energy X-ray absorptiometry
Measured: ! day
Vertebral fracture
With the help of plain X-ray
Measured: ! day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Mar 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limin Rong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Kishor Chhantyal, MBBS, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605173
- Sponsor's protocol ID
- free vitamin d - bmd
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32164704
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?
- ClinicalTrials.gov ID
- NCT03605173
- Acronym / sponsor ID
- free vitamin d - bmd
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Limin RongUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free vitamin d | Experimental | Diagnostic Test: free vitamin d testfree vitamin is directly measured from blood serum using an ELISA kit |
| total vitamin d | Experimental | Diagnostic Test: total vitamin dTotal vitamin d is measured routinely from blood serum |
Who may qualify
- Ages
- 48 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a diagnosis of osteoporosis and with or without fracture
- post- menopausal women
- age > 48 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| free vitamin d testusing the patient's blood serum ELISA test for free vitamin d can be performed | Diagnostic test | free vitamin d |
| total vitamin droutinely measured from serum | Diagnostic test | total vitamin d |
Primary outcome
Free vitamin D
Time frame: ! day
measured using free vitamin D Elisa kit
Total vitamin D
Time frame: ! day
It is measured as a part of routine investigation at the time of admission
2 secondary outcomes
BMD
Time frame: ! day
Vertebral fracture
Time frame: ! day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 32164704Chhantyal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kishor Chhantyal, MBBS principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free vitamin d test and total vitamin d in people with Osteoporosis, run by Limin Rong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Min Rong, MD (862085252900, ronglimin@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free vitamin D (time frame: ! day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.