Vitamin B12 DeficiencyNCT01297361
The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
A study testing Blood Sample in people with Vitamin B12 Deficiency and Folic Acid Deficiency, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Deficiency, Folic Acid Deficiency
- What is being tested?
- Blood Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18 and older
- Able to understand and to sign informed consent
Who cannot join
- Gastrointistinal Diseases
- Malignancy
- Psychiatric disorders
- Pregnancy
- Treatment with Vit B12 or Folic acid
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vitamin B12 Deficiency, Folic Acid Deficiency
- Being tested
- Blood Sample
- Medical subject headings
- Vitamin B 12 Deficiency, Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
Blood sampling for diagnosis of vitamins deficiencies
| Study group | Role | What they receive |
|---|---|---|
| Plasma Vitamin B12 and Folic acid levels | Other | Blood sample was drawn Receives: Other: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297361
- Sponsor's protocol ID
- K.Hassan
- Status last verified
- Mar 2012
- First submitted
- 2 Jan 2011
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
- ClinicalTrials.gov ID
- NCT01297361
- Acronym / sponsor ID
- K.Hassan
- Conditions
- Vitamin B12 Deficiency, Folic Acid Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma Vitamin B12 and Folic acid levels | Other | Other: Blood SampleBlood sample was drawn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age:18 and older
- Able to understand and to sign informed consent
Key exclusion criteria (5 listed)
- Gastrointistinal Diseases
- Malignancy
- Psychiatric disorders
- Pregnancy
- Treatment with Vit B12 or Folic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleBlood sampling for diagnosis of vitamins deficiencies | Other | Plasma Vitamin B12 and Folic acid levels |
Primary outcome
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Sample in people with Vitamin B12 Deficiency and Folic Acid Deficiency, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants of each religious origin group with folic acid deficiency (time frame: 10 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.