- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01297361
The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
April 22, 2013 updated by: Meir Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kfar Yassif, Israel, 24908
- Clalit Health Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Plasma Vitamin B12 and Folic acid levels
Blood sample was drawn
|
Blood sampling for diagnosis of vitamins deficiencies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participants of each religious origin group with folic acid deficiency
Time Frame: 10 months
|
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.
|
10 months
|
The number of participants of each age group with Vitamin B12 deficiency
Time Frame: 10 months
|
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
|
10 months
|
The number of participants of each age group with folic acid deficiency
Time Frame: 10 months
|
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
|
10 months
|
The number of participants of each religious origin group with Vitamin B12 deficiency
Time Frame: 10 months
|
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.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
January 2, 2011
First Submitted That Met QC Criteria
February 15, 2011
First Posted (Estimate)
February 16, 2011
Study Record Updates
Last Update Posted (Estimate)
April 23, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K.Hassan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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