Vitamin D DeficiencyNCT02795234
Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples
A study testing Blood samples in people with Vitamin D Deficiency, run by Meir Medical Center.
Trial summary
The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer. A second goal is to find the relation between Vitamin D Antibody and Vitamin D level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients treated in Meir Medical Center
- Data on serum vitamin D values
- 18 years old
- Both sexes
- Patient hereby declare that he\she agree to participate the clinical trial
Who cannot join
- Patient refuses to sign Informed Consent.
- Patients without vitamin D values
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples And The Correlation Between Vitamin D Level
The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer. A second goal is to find the relation between Vitamin D Antibody and Vitamin D level.
Read the detailed description
Vitamin D and its metabolites have a significant role in the calcium homeostasis and bone metabolism. Vitamin D deficiency as measured by serum 25(OH)D below 20 ng/mL (50 nmol/L) may contribute to the development of osteoporosis and Osteomalacia.
Several studies have clearly demonstrated that low 25(OH)D levels are associated with more comorbidities, higher estimated cardiovascular risk and autoimmune diseases.
Exposure to the ultraviolet (UV) rays in sunlight is the major source of vitamin D. other sources are dairy products enriched with vitamin D.
Vitamin D deficiency can result from inadequate exposure to sunlight, malabsorption including inflammatory bowel disease, celiac disease and patients undergone resection of the small intestine and inadequate intake of dairy products enriched with vitamin D.
Another possible explanation for vitamin D deficiency is the presence of neutralizing autoantibodies to vitamin D.
The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer
At least 64 Blood samples of Patients and healthy volunteer will be tested for the presence of auto-antibodies using an ELISA reader.
The result will compare antibody-positive and antibody-negative individuals with respect of serum 25(OH)D level and other variables and to find the relation between Vitamin D Antibody and Vitamin D level.
- Conditions
- Vitamin D Deficiency
- Being tested
- Blood samples
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Participants with Vitamin D deficiency | Other | Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies Receives: Other: Blood samples |
| Participants with sufficient Vitamin D Level | Other | Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Anti Vitamin D Antibodies in Blood Sample
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair levy, Meir Medical Center
- Investigators
- reut ohanah, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795234
- Sponsor's protocol ID
- Vitamin D 25 - 2016
- Status last verified
- Jun 2016
- First submitted
- 5 Jun 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples And The Correlation Between Vitamin D Level
- ClinicalTrials.gov ID
- NCT02795234
- Acronym / sponsor ID
- Vitamin D 25 - 2016
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- 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.
The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer. A second goal is to find the relation between Vitamin D Antibody and Vitamin D level.
Detailed description
Vitamin D and its metabolites have a significant role in the calcium homeostasis and bone metabolism. Vitamin D deficiency as measured by serum 25(OH)D below 20 ng/mL (50 nmol/L) may contribute to the development of osteoporosis and Osteomalacia.
Several studies have clearly demonstrated that low 25(OH)D levels are associated with more comorbidities, higher estimated cardiovascular risk and autoimmune diseases.
Exposure to the ultraviolet (UV) rays in sunlight is the major source of vitamin D. other sources are dairy products enriched with vitamin D.
Vitamin D deficiency can result from inadequate exposure to sunlight, malabsorption including inflammatory bowel disease, celiac disease and patients undergone resection of the small intestine and inadequate intake of dairy products enriched with vitamin D.
Another possible explanation for vitamin D deficiency is the presence of neutralizing autoantibodies to vitamin D.
The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer
At least 64 Blood samples of Patients and healthy volunteer will be tested for the presence of auto-antibodies using an ELISA reader.
The result will compare antibody-positive and antibody-negative individuals with respect of serum 25(OH)D level and other variables and to find the relation between Vitamin D Antibody and Vitamin D level.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Vitamin D deficiency | Other | Other: Blood samplesBlood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies |
| Participants with sufficient Vitamin D Level | Other | Other: Blood samplesBlood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients treated in Meir Medical Center
- Data on serum vitamin D values
- 18 years old
- Both sexes
- Patient hereby declare that he\she agree to participate the clinical trial
Key exclusion criteria (2 listed)
- Patient refuses to sign Informed Consent.
- Patients without vitamin D values
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 |
|---|---|---|
| Blood samples | Other | Participants with Vitamin D deficiency, Participants with sufficient Vitamin D Level |
Primary outcome
Presence of Anti Vitamin D Antibodies in Blood Sample
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
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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.
reut ohanah principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Vitamin D Deficiency, run by Meir Medical Center.
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 5 inclusion and 2 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 10 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yair levy, MD (: 972-09-7472592, levy.yair@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Anti Vitamin D Antibodies in Blood Sample (time frame: 1 year). 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 10 Jun 2016.