Trial record 3 of 82 for:    vitamin B12 deficiency

Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Keesler Air Force Base Medical Center
Sponsor:
Information provided by (Responsible Party):
Matthew B. Carroll, LtCol, USAF, MC, FACP, FACR, Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier:
NCT01876329
First received: June 9, 2013
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition
Vitamin B12 Deficiency
Autoantibodies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Presence of Autoantibodies to Gastric Parietal Cells and Subsequent Vitamin B12 Deficiency in Rheumatoid Arthritis Patients

Resource links provided by NLM:


Further study details as provided by Keesler Air Force Base Medical Center:

Primary Outcome Measures:
  • Prevalence of vitamin B12 deficiency [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Presence of anti-GPC antibodies [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 135
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited from the Internal Medicine and Internal Medicine Specialty Clinics at one academic community hospital.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT01876329

Contacts
Contact: Matthew B Carroll, MD 228-376-3629 matthew.carroll.1@us.af.mil

Locations
United States, Mississippi
Keesler Medical Center Recruiting
Keesler AFB, Mississippi, United States, 39534
Contact: Matthew B Carroll, MD    228-376-3629    matthew.carroll.1@us.af.mil   
Principal Investigator: Matthew B Carroll, MD         
Sub-Investigator: Christopher Tessier, MD         
Sponsors and Collaborators
Keesler Air Force Base Medical Center
Investigators
Principal Investigator: Matthew B Carroll, MD Keesler Medical Center
  More Information

No publications provided

Responsible Party: Matthew B. Carroll, LtCol, USAF, MC, FACP, FACR, Chief of Rheumatology, Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier: NCT01876329     History of Changes
Other Study ID Numbers: FKE20130010H
Study First Received: June 9, 2013
Last Updated: May 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Keesler Air Force Base Medical Center:
Rheumatoid Arthritis
Vitamin B12 deficiency
Autoimmune Thyroid Disease
Autoantibodies

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Vitamin B Complex
Vitamins
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Avitaminosis
Malnutrition
Nutrition Disorders
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014