Meniere DiseaseNCT05322538
Menier's Disease - Bone Density Study
A study testing vitamin D plasma levels baseline, Dual-energy X-ray absorptiometry at baseline and cervical Vestibular evoked myogenic potentials at baseline in people with Meniere Disease and Osteoporosis, run by HaEmek Medical Center, Israel.
Trial summary
Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meniere Disease, Osteoporosis, Osteopenia
- What is being tested?
- vitamin D plasma levels baseline, Dual-energy X-ray absorptiometry at baseline and cervical Vestibular evoked myogenic potentials at baseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Definite Meniere's disease
Who cannot join
- hyperthyroidism
- hyperparathyroidism
- acromegaly
- hypogonadism
- diabetes melitus
- chronic renal failure
Show all 20Show fewer
- alcoholism
- cushing syndrome
- rheumatoid arthritis
- systemic lupus erythematosus
- ankylosing spondylitis
- inflammatory bowel disease
- obstructive lung disease
- sarcoidosis
- amyloidosis
- celiac disease.
- chronic treatment with bisphosphonates
- chronic treatment with glucocorticoids
- chronic treatment with androgen deprivation therapy
- chronic treatment with gonadotropin releasing hormone agonist chronic treatment with aromatase inhibitor chronic treatment with loop diuretics chronic treatment with proton pump inhibitors chronic treatment with anti-seizure drugs chronic treatment with warfarin chronic treatment with SSRI chronic treatment with alpha or beta-blockers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Miki Peker, M/D contact
About this study
Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. In the current prospective study definite Meniere's patients will be followed over a period of 2 year, during which repetitive measurements of bone density, vitamin D plasma levels, blood pressure as well as hearing and vestibular tests will be made. Results will be compared to healthy controls.
- Being tested
- vitamin D plasma levels baseline, Dual-energy X-ray absorptiometry at baseline, cervical Vestibular evoked myogenic potentials at baseline, Audiogram at baseline, Measuring Orthostatic Blood Pressure at baseline
- Medical subject headings
- Meniere Disease, Osteoporosis, Bone Diseases, Metabolic, Vitamin D Deficiency, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D plasma levels baselineDiagnostic test
Measuring vitamin D plasma levels at baseline
Dual-energy X-ray absorptiometry at baselineDiagnostic test
Also called DEXA
Measuring T-score and Z-score of the femur and lumbar spine at baseline
cervical Vestibular evoked myogenic potentials at baselineDiagnostic test
Also called cVEMP
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured.
Audiogram at baselineDiagnostic test
Also called Hearing test
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score.
Measuring Orthostatic Blood Pressure at baselineDiagnostic test
Also called Orthostatic Hypotension
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test
cold pressor test at baselineDiagnostic test
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function.
vitamin D plasma levels one year after recruitmentDiagnostic test
Measuring vitamin D plasma levels one year after recruitment
vitamin D plasma levels two years after recruitmentDiagnostic test
Measuring vitamin D plasma levels two years after recruitment
Dual-energy X-ray absorptiometry one year after recruitmentDiagnostic test
Also called DEXA
Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment
Dual-energy X-ray absorptiometry two years after recruitmentDiagnostic test
Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment
cervical Vestibular evoked myogenic potentials one year after recruitmentDiagnostic test
Also called cVEMP
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured one year after recruitment
cervical Vestibular evoked myogenic potentials two years after recruitmentDiagnostic test
Also called cVEMP
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured two years after recruitment
Audiogram one year after recruitmentDiagnostic test
Also called Hearing test
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed one year after recruitment
Audiogram two years after recruitmentDiagnostic test
Also called Hearing test
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed two years after recruitment
Measuring Orthostatic Blood Pressure one year after recruitmentDiagnostic test
Also called Ortostatic hypostension
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed one year after recruitment
Measuring Orthostatic Blood Pressure two years after recruitmentDiagnostic test
Also called Ostostatic hypotension
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed two year after recruitment.
cold pressor test one year after recruitmentDiagnostic test
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed one year after recruitment.
cold pressor test two years after recruitmentDiagnostic test
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed two years after recruitment.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Other | Healthy controls with no known vestibular disease Receives: Diagnostic Test: vitamin D plasma levels baseline; Diagnostic Test: Dual-energy X-ray absorptiometry at baseline; Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline; Diagnostic Test: cold pressor test at baseline |
| Definite Meniere's disease | Experimental | Patients with Definite Meniere's disease Receives: Diagnostic Test: vitamin D plasma levels baseline; Diagnostic Test: Dual-energy X-ray absorptiometry at baseline; Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline; Diagnostic Test: Audiogram at baseline; Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline; Diagnostic Test: cold pressor test at baseline; Diagnostic Test: vitamin D plasma levels one year after recruitment; Diagnostic Test: vitamin D plasma levels two years after recruitment; Diagnostic Test: Dual-energy X-ray absorptiometry one year after recruitment; Diagnostic Test: Dual-energy X-ray absorptiometry two years after recruitment; Diagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitment; Diagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitment; Diagnostic Test: Audiogram one year after recruitment; Diagnostic Test: Audiogram two years after recruitment; Diagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitment; Diagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitment; Diagnostic Test: cold pressor test one year after recruitment; Diagnostic Test: cold pressor test two years after recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D plasma levels
Vitamin D plasma levels
Measured: baseline
Vitamin D plasma levels
Vitamin D plasma levels
Measured: one year follow up
Vitamin D plasma levels
Vitamin D plasma levels
Measured: two years follow-up
Z-score and T-score of femur and lumbur spine
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
Measured: baseline
Z-score and T-score of femur and lumbur spine
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
Measured: one year follow up
Z-score and T-score of femur and lumbur spine
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
Measured: two years follow-up
Secondary outcomes (12)
positive ortostatic hypotension
drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
Measured: baseline
positive ortostatic hypotension
drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
Measured: one year follow up
positive ortostatic hypotension
drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
Measured: Two years follow-up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
Measured: baseline
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
Measured: one year follow up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
Measured: two years follow-up
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
cervical vestibular evoked myogenic potential exam
Measured: baseline
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
cervical vestibular evoked myogenic potential exam
Measured: one year follow up
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
cervical vestibular evoked myogenic potential exam
Measured: two years follow-up
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
audiology exam
Measured: baseline
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
audiology exam
Measured: one year follow up
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
audiology exam
Measured: two years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paker Miki, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322538
- Sponsor's protocol ID
- EMC-22-0031
- Status last verified
- Aug 2022
- First submitted
- 16 Mar 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menier's Disease - Bone Density Study
- ClinicalTrials.gov ID
- NCT05322538
- Acronym / sponsor ID
- EMC-22-0031
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Apr 2022 (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.
Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. In the current prospective study definite Meniere's patients will be followed over a period of 2 year, during which repetitive measurements of bone density, vitamin D plasma levels, blood pressure as well as hearing and vestibular tests will be made. Results will be compared to healthy controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Other | Diagnostic Test: vitamin D plasma levels baseline, Diagnostic Test: Dual-energy X-ray absorptiometry at baseline, Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline, Diagnostic Test: cold pressor test at baselineHealthy controls with no known vestibular disease |
| Definite Meniere's disease | Experimental | Diagnostic Test: vitamin D plasma levels baseline, Diagnostic Test: Dual-energy X-ray absorptiometry at baseline, Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline, Diagnostic Test: Audiogram at baseline, Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline, Diagnostic Test: cold pressor test at baseline, Diagnostic Test: vitamin D plasma levels one year after recruitment, Diagnostic Test: vitamin D plasma levels two years after recruitment, Diagnostic Test: Dual-energy X-ray absorptiometry one year after recruitment, Diagnostic Test: Dual-energy X-ray absorptiometry two years after recruitment, Diagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitment, Diagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitment, Diagnostic Test: Audiogram one year after recruitment, Diagnostic Test: Audiogram two years after recruitment, Diagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitment, Diagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitment, Diagnostic Test: cold pressor test one year after recruitment, Diagnostic Test: cold pressor test two years after recruitmentPatients with Definite Meniere's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Definite Meniere's disease
Key exclusion criteria (20 listed)
- hyperthyroidism
- hyperparathyroidism
- acromegaly
- hypogonadism
- diabetes melitus
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 |
|---|---|---|
| vitamin D plasma levels baselineMeasuring vitamin D plasma levels at baseline | Diagnostic test | Controls, Definite Meniere's disease |
| Dual-energy X-ray absorptiometry at baselineAlso: DEXAMeasuring T-score and Z-score of the femur and lumbar spine at baseline | Diagnostic test | Controls, Definite Meniere's disease |
| cervical Vestibular evoked myogenic potentials at baselineAlso: cVEMPcVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured. | Diagnostic test | Definite Meniere's disease |
| Audiogram at baselineAlso: Hearing testhearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score. | Diagnostic test | Definite Meniere's disease |
| Measuring Orthostatic Blood Pressure at baselineAlso: Orthostatic Hypotensionblood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test | Diagnostic test | Controls, Definite Meniere's disease |
| cold pressor test at baselineThe cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. | Diagnostic test | Controls, Definite Meniere's disease |
| vitamin D plasma levels one year after recruitmentMeasuring vitamin D plasma levels one year after recruitment | Diagnostic test | Definite Meniere's disease |
| vitamin D plasma levels two years after recruitmentMeasuring vitamin D plasma levels two years after recruitment | Diagnostic test | Definite Meniere's disease |
| Dual-energy X-ray absorptiometry one year after recruitmentAlso: DEXAMeasuring T-score and Z-score of the femur and lumbar spine one year after recruitment | Diagnostic test | Definite Meniere's disease |
| Dual-energy X-ray absorptiometry two years after recruitmentMeasuring T-score and Z-score of the femur and lumbar spine two years after recruitment | Diagnostic test | Definite Meniere's disease |
| cervical Vestibular evoked myogenic potentials one year after recruitmentAlso: cVEMPcVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured one year after recruitment | Diagnostic test | Definite Meniere's disease |
| cervical Vestibular evoked myogenic potentials two years after recruitmentAlso: cVEMPcVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured two years after recruitment | Diagnostic test | Definite Meniere's disease |
| Audiogram one year after recruitmentAlso: Hearing testhearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed one year after recruitment | Diagnostic test | Definite Meniere's disease |
| Audiogram two years after recruitmentAlso: Hearing testhearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed two years after recruitment | Diagnostic test | Definite Meniere's disease |
| Measuring Orthostatic Blood Pressure one year after recruitmentAlso: Ortostatic hypostensionblood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed one year after recruitment | Diagnostic test | Definite Meniere's disease |
| Measuring Orthostatic Blood Pressure two years after recruitmentAlso: Ostostatic hypotensionblood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed two year after recruitment. | Diagnostic test | Definite Meniere's disease |
| cold pressor test one year after recruitmentThe cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed one year after recruitment. | Diagnostic test | Definite Meniere's disease |
| cold pressor test two years after recruitmentThe cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed two years after recruitment. | Diagnostic test | Definite Meniere's disease |
Primary outcome
Vitamin D plasma levels
Time frame: baseline
Vitamin D plasma levels
Vitamin D plasma levels
Time frame: one year follow up
Vitamin D plasma levels
Vitamin D plasma levels
Time frame: two years follow-up
Vitamin D plasma levels
Z-score and T-score of femur and lumbur spine
Time frame: baseline
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
Z-score and T-score of femur and lumbur spine
Time frame: one year follow up
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
Z-score and T-score of femur and lumbur spine
Time frame: two years follow-up
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
12 secondary outcomes
positive ortostatic hypotension
Time frame: baseline
positive ortostatic hypotension
Time frame: one year follow up
positive ortostatic hypotension
Time frame: Two years follow-up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
Time frame: baseline
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
Time frame: one year follow up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
Time frame: two years follow-up
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
Time frame: baseline
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
Time frame: one year follow up
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
Time frame: two years follow-up
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
Time frame: baseline
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
Time frame: one year follow up
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
Time frame: two years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Miki Peker, M/D contact
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D plasma levels baseline, Dual-energy X-ray absorptiometry at baseline and cervical Vestibular evoked myogenic potentials at baseline in people with Meniere Disease and Osteoporosis, run by HaEmek Medical Center, Israel.
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 1 inclusion and 20 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: opening soon, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoni Evgeni Gutkovich, M.D\Ph.D (+972-526894497, gutkovichj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D plasma levels (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.