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Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795234
Recruitment Status : Unknown
Verified June 2016 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
yair levy, Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Other: Blood samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Participants with Vitamin D deficiency
Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies
Other: Blood samples
Participants with sufficient Vitamin D Level
Blood sample, venous blood, about 10 ml will be drawn from participants and tested for the presence of Vitamin D antibodies
Other: Blood samples



Primary Outcome Measures :
  1. Presence of Anti Vitamin D Antibodies in Blood Sample [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795234


Contacts
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Contact: Yair levy, MD : 972-09-7472592 levy.yair@clalit.org.il
Contact: Yael Eizikovits, SC 972-09-7471936 yael.eizikovits@clalit.org.il

Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: reut ohanah Meir Medical Center
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Responsible Party: yair levy, Head of Internal Medicine, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02795234    
Other Study ID Numbers: Vitamin D 25 - 2016
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders