The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
Primary Purpose
Vitamin B12 Deficiency, Folic Acid Deficiency
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood Sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin B12 Deficiency
Eligibility Criteria
Inclusion Criteria:
- Age:18 and older
- Able to understand and to sign informed consent
Exclusion Criteria:
- Gastrointistinal Diseases
- Malignancy
- Psychiatric disorders
- Pregnancy
- Treatment with Vit B12 or Folic acid
Sites / Locations
- Clalit health services
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Plasma Vitamin B12 and Folic acid levels
Arm Description
Blood sample was drawn
Outcomes
Primary Outcome Measures
The number of participants of each religious origin group with folic acid deficiency
The association between religious origin (Christians,Muslims and Druze) and folic acid plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of this vitamin will be treated accordingly.
The number of participants of each age group with Vitamin B12 deficiency
The association between age groups (18-40, 41-65 and above 65 years old) and Vitamin B12 plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of this vitamin will be treated accordingly
The number of participants of each age group with folic acid deficiency
The association between age groups (18-40, 41-65 and above 65 years old) and folic acid plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of this vitamin will be treated accordingly
The number of participants of each religious origin group with Vitamin B12 deficiency
The association between religious origin (Cristians, Muslims and Druze) and Vitamin B12 plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of these vitamins will be treated accordingly.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01297361
Brief Title
The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vitamin B12 deficiency is more widespread in the population than has been assumed so far. Since a deficiency in this vitamin can lead to irreversible neurological damage, early diagnosis is essential. Vitamin B12 is synthesized exclusively in micro-organisms, and in humans it is an essential component in methyl group transfer and cell division. The vitamin is crucially involved in the proliferation, maturation, and regeneration of neural cells. In combination with folic acid, as an enzymatic essential cofactor in the metabolism of homocysteine, vitamin B12 maintains low homocysteine levels. The aim of the present study is to investigate the relationship between religious origin and age, and Vitamin B12 and Folic acid plasma levels in non Jewish population in Western Galilee. The investigators assumption is that the results of the study will contribute to early detection and treatment of Vitamin B12 and Folic acid deficiencies in order to prevent long term complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B12 Deficiency, Folic Acid Deficiency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasma Vitamin B12 and Folic acid levels
Arm Type
Other
Arm Description
Blood sample was drawn
Intervention Type
Other
Intervention Name(s)
Blood Sample
Intervention Description
Blood sampling for diagnosis of vitamins deficiencies
Primary Outcome Measure Information:
Title
The number of participants of each religious origin group with folic acid deficiency
Description
The association between religious origin (Christians,Muslims and Druze) and folic acid plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of this vitamin will be treated accordingly.
Time Frame
10 months
Title
The number of participants of each age group with Vitamin B12 deficiency
Description
The association between age groups (18-40, 41-65 and above 65 years old) and Vitamin B12 plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of this vitamin will be treated accordingly
Time Frame
10 months
Title
The number of participants of each age group with folic acid deficiency
Description
The association between age groups (18-40, 41-65 and above 65 years old) and folic acid plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of this vitamin will be treated accordingly
Time Frame
10 months
Title
The number of participants of each religious origin group with Vitamin B12 deficiency
Description
The association between religious origin (Cristians, Muslims and Druze) and Vitamin B12 plasma levels will be investigated by one blood analysis taken once at commence of trial (Day 1). Patients found to have low levels of these vitamins will be treated accordingly.
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age:18 and older
Able to understand and to sign informed consent
Exclusion Criteria:
Gastrointistinal Diseases
Malignancy
Psychiatric disorders
Pregnancy
Treatment with Vit B12 or Folic acid
Facility Information:
Facility Name
Clalit health services
City
Kfar Yassif
ZIP/Postal Code
24908
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
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