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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
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients treated in Meir Medical Center
  2. Data on serum vitamin D values
  3. 18 years old
  4. Both sexes
  5. Patient hereby declare that he\she agree to participate the clinical trial

Exclusion Criteria:

  1. Patient refuses to sign Informed Consent.
  2. 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

    First Posted
    June 5, 2016
    Last Updated
    June 9, 2016
    Sponsor
    Meir Medical Center
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    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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