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

NCT ID: NCT02795234

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Blood samples

Intervention Type: OTHER

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

Group Type: OTHER

Blood samples

Intervention Type: OTHER

Interventions

Blood samples

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

yair levy

Head of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

reut ohanah

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Central Contacts

Yair levy, MD

Role: CONTACT

levy.yair@clalit.org.il

: 972-09-7472592

Yael Eizikovits, SC

Role: CONTACT

yael.eizikovits@clalit.org.il

972-09-7471936

Other Identifiers

Vitamin D 25 - 2016

Identifier Type: -

Identifier Source: org_study_id