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

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Clalit Health Services

Status

Unknown

Conditions

Vitamin D Deficiency

Treatments

Other: Blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02795234
Vitamin D 25 - 2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Yair levy, MD; Yael Eizikovits, SC

Data sourced from clinicaltrials.gov

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