Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples
Primary Purpose
Vitamin D Deficiency
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient refuses to sign Informed Consent.
- Patients without vitamin D values
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Participants with Vitamin D deficiency
Participants with sufficient Vitamin D Level
Arm Description
Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies
Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies
Outcomes
Primary Outcome Measures
Presence of Anti Vitamin D Antibodies in Blood Sample
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02795234
Brief Title
Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with Vitamin D deficiency
Arm Type
Other
Arm Description
Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies
Arm Title
Participants with sufficient Vitamin D Level
Arm Type
Other
Arm Description
Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies
Intervention Type
Other
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
Presence of Anti Vitamin D Antibodies in Blood Sample
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient refuses to sign Informed Consent.
Patients without vitamin D values
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair levy, MD
Phone
: 972-09-7472592
Email
levy.yair@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Eizikovits, SC
Phone
972-09-7471936
Email
yael.eizikovits@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
reut ohanah
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples
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