NCT01297361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 23, 2013

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

January 2, 2011

Last Update Submit

April 22, 2013

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    10 months

  • 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

    10 months

  • 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

    10 months

  • 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.

    10 months

Study Arms (1)

Plasma Vitamin B12 and Folic acid levels

OTHER

Blood sample was drawn

Other: Blood Sample

Interventions

Blood sampling for diagnosis of vitamins deficiencies

Plasma Vitamin B12 and Folic acid levels

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:18 and older
  • Able to understand and to sign informed consent

You may not qualify if:

  • Gastrointistinal Diseases
  • Malignancy
  • Psychiatric disorders
  • Pregnancy
  • Treatment with Vit B12 or Folic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit health services

Kfar Yassif, 24908, Israel

Location

MeSH Terms

Conditions

Vitamin B 12 DeficiencyFolic Acid Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2011

First Posted

February 16, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2011

Study Completion

August 1, 2012

Last Updated

April 23, 2013

Record last verified: 2012-03

Locations