The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01297361
First received: January 2, 2011
Last updated: April 22, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention
Vitamin B12 Deficiency
Folic Acid Deficiency
Other: Blood Sample

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The number of participants of each religious origin group with folic acid deficiency [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Plasma Vitamin B12 and Folic acid levels
Blood sample was drawn
Other: Blood Sample
Blood sampling for diagnosis of vitamins deficiencies

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297361

Locations
Israel
Clalit health services
Kfar Yassif, Israel, 24908
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01297361     History of Changes
Other Study ID Numbers: K.Hassan
Study First Received: January 2, 2011
Last Updated: April 22, 2013
Health Authority: Israel: Clalit Health Services

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Folic Acid Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin B 12
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamin B Complex

ClinicalTrials.gov processed this record on September 22, 2014