Vitamin B12 DeficiencyNCT01876329
Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients
An observational study of Vitamin B12 Deficiency, run by Keesler Air Force Base Medical Center at 1 site in United States.
Trial summary
A review of the literature reveals that very few studies have assessed the potential co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While Segal et al. 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
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Participants will be recruited from the Internal Medicine and Internal Medicine Specialty Clinics at one academic community hospital.
Who may be able to join
- Adult, age 18 and older
- RA arm: History of Rheumatoid Arthritis
- AITD arm: History of an autoimmune thyroid disease without a history or clinically obvious manifestation of an organ specific or systemic autoimmune process.
- Control arm: No history of RA and no history or clinically obvious manifestation of an organ specific or systemic autoimmune process.
Who cannot join
- Known vitamin B12 deficiency for which the participant was formerly treated or continues to receive therapy.
- Active malabsorptive state to include but not limited to celiac disease, inflammatory bowel disease, etc.
- Surgically induced malabsorptive state to include but not limited to Roux-en-Y Gastric bypass
- Use of medications that may interfere with vitamin B12 absorption
- Patients with a thyroid condition not consistent with an autoantibody process (i.e. congenital absence of the thyroid, infectious thyroiditis, thyroidectomy for non-autoimmune process, toxic multinodular goiter) will be excluded from the autoimmune thyroid arm.
Trial locations and contacts
1 site in 1 country.
United States1 site
Keesler Medical Center
Keesler Air Force Base, Mississippi, 39534
About this study
Official title: Presence of Autoantibodies to Gastric Parietal Cells and Subsequent Vitamin B12 Deficiency in Rheumatoid Arthritis Patients
A review of the literature reveals that very few studies have assessed the potential co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While Segal et al. in 2004 published a study which found that 49% of patients with RA had vitamin B12 deficiency, no assessment of the etiology or the presence of autoantibodies was made. While Goeldner et al. in 2011 and Datta et al. in 1990 demonstrated that anti-gastric parietal cell antibodies (anti-GPC Ab) were found in <5% to 28% of RA patients respectively, no additional testing was implemented to determine the significance, specifically whether or not the presence of anti-GPC Ab related to vitamin B12 deficiency.
The purpose of this study is to determine the prevalence and metabolic significance of anti-GPC Ab in three cohorts: (1) a group of patients with Rheumatoid Arthritis, (2) a group of patients with autoimmune thyroid disease (AITD), and (3) a group of patients with neither RA or AITD. To determine the significance of the presence of anti-GPC Ab, testing of the current serum B12 level along with a metabolite dependent on adequate vitamin B12 levels (Methylmalonic acid) will be tested.
Read the detailed description
Background: Organ specific antibodies such as anti-gastric parietal cell antibodies (anti-GPC Ab) have been found in a variable number of patients with RA, but it is unclear what significance these antibodies have on actual vitamin B12 levels. Patients with RA have been found to have vitamin B12 deficiency up to near 50% but it is unclear if this deficiency is due to anti-GPC Ab.
Hypothesis: By virtue of the aberrant autoimmune process that occurs in RA, patients with RA are more likely to have anti-GPC Ab and more likely than a control arm or participants with autoimmune thyroid disease (AITD) to have vitamin B12 deficiency.
Method: 135 patients will be consented; 45 to the RA arm, 45 to an AITD arm, and 45 to a control arm. Exclusion criteria will filter patients who would have other reasons for altered vitamin B12 absorption, such as inflammatory bowel disease, surgery, or medication use. After obtaining consent subjects will be sent to lab a serum anti-GPC Ab test (obtainable in an SLE panel), RF, B12/folate (as available for ordering in CHCS), methyl malonic acid, and (for the control arm subjects and AITD subjects) an anti-CCP IgG. Patients will also complete a one-sided, one page questionnaire asking them about dietary and medication exposures.
Outcomes: (1) Determine whether evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab. (2) Determine the prevalence of anti-GPC Ab in a group of patients with RA as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Rheumatoid Arthritis, Vitamin B12 deficiency, Autoimmune Thyroid Disease, Autoantibodies
- Medical subject headings
- Vitamin B 12 Deficiency, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Patients with seropositive or seronegative Rheumatoid Arthritis | |
| Autoimmune Thyroid Disease (AITD) | Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses. | |
| Control | Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Vitamin B12 Deficiency
Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.
Measured: 7 months
Secondary outcomes (1)
Presence of Anti-GPC Antibodies
Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keesler Air Force Base Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Matthew B. Carroll, LtCol, USAF, MC, FACP, FACR, Keesler Air Force Base Medical Center
- Investigators
- Matthew B Carroll, MD, Principal investigator, Keesler Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876329
- Sponsor's protocol ID
- FKE20130010H
- Status last verified
- May 2015
- First submitted
- 9 Jun 2013
- Last updated
- 29 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Autoantibodies to Gastric Parietal Cells and Subsequent Vitamin B12 Deficiency in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01876329
- Acronym / sponsor ID
- FKE20130010H
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Rheumatoid Arthritis, Vitamin B12 deficiency, Autoimmune Thyroid Disease, Autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Keesler Air Force Base Medical CenterUS federal agency
- Study start
- Jun 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A review of the literature reveals that very few studies have assessed the potential co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While Segal et al. in 2004 published a study which found that 49% of patients with RA had vitamin B12 deficiency, no assessment of the etiology or the presence of autoantibodies was made. While Goeldner et al. in 2011 and Datta et al. in 1990 demonstrated that anti-gastric parietal cell antibodies (anti-GPC Ab) were found in <5% to 28% of RA patients respectively, no additional testing was implemented to determine the significance, specifically whether or not the presence of anti-GPC Ab related to vitamin B12 deficiency.
The purpose of this study is to determine the prevalence and metabolic significance of anti-GPC Ab in three cohorts: (1) a group of patients with Rheumatoid Arthritis, (2) a group of patients with autoimmune thyroid disease (AITD), and (3) a group of patients with neither RA or AITD. To determine the significance of the presence of anti-GPC Ab, testing of the current serum B12 level along with a metabolite dependent on adequate vitamin B12 levels (Methylmalonic acid) will be tested.
Detailed description
Background: Organ specific antibodies such as anti-gastric parietal cell antibodies (anti-GPC Ab) have been found in a variable number of patients with RA, but it is unclear what significance these antibodies have on actual vitamin B12 levels. Patients with RA have been found to have vitamin B12 deficiency up to near 50% but it is unclear if this deficiency is due to anti-GPC Ab.
Hypothesis: By virtue of the aberrant autoimmune process that occurs in RA, patients with RA are more likely to have anti-GPC Ab and more likely than a control arm or participants with autoimmune thyroid disease (AITD) to have vitamin B12 deficiency.
Method: 135 patients will be consented; 45 to the RA arm, 45 to an AITD arm, and 45 to a control arm. Exclusion criteria will filter patients who would have other reasons for altered vitamin B12 absorption, such as inflammatory bowel disease, surgery, or medication use. After obtaining consent subjects will be sent to lab a serum anti-GPC Ab test (obtainable in an SLE panel), RF, B12/folate (as available for ordering in CHCS), methyl malonic acid, and (for the control arm subjects and AITD subjects) an anti-CCP IgG. Patients will also complete a one-sided, one page questionnaire asking them about dietary and medication exposures.
Outcomes: (1) Determine whether evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab. (2) Determine the prevalence of anti-GPC Ab in a group of patients with RA as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | –Patients with seropositive or seronegative Rheumatoid Arthritis |
| Autoimmune Thyroid Disease (AITD) | – | –Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses. |
| Control | – | –Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Internal Medicine and Internal Medicine Specialty Clinics at one academic community hospital.
Key inclusion criteria (4 listed)
- Adult, age 18 and older
- RA arm: History of Rheumatoid Arthritis
- AITD arm: History of an autoimmune thyroid disease without a history or clinically obvious manifestation of an organ specific or systemic autoimmune process.
- Control arm: No history of RA and no history or clinically obvious manifestation of an organ specific or systemic autoimmune process.
Key exclusion criteria (5 listed)
- Known vitamin B12 deficiency for which the participant was formerly treated or continues to receive therapy.
- Active malabsorptive state to include but not limited to celiac disease, inflammatory bowel disease, etc.
- Surgically induced malabsorptive state to include but not limited to Roux-en-Y Gastric bypass
- Use of medications that may interfere with vitamin B12 absorption
- Patients with a thyroid condition not consistent with an autoantibody process (i.e. congenital absence of the thyroid, infectious thyroiditis, thyroidectomy for non-autoimmune process, toxic multinodular goiter) will be excluded from the autoimmune thyroid arm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Vitamin B12 Deficiency
Time frame: 7 months
Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.
1 secondary outcome
Presence of Anti-GPC Antibodies
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Matthew B Carroll, MD principal investigator
Keesler Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin B12 Deficiency, run by Keesler Air Force Base Medical Center at 1 site in United States.
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 4 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 29 May 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Vitamin B12 Deficiency (time frame: 7 months). 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 29 May 2015.