Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients

NCT01876329 | Completed Results

• 1 other identifier: FKE20130010H
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vitamin B12 Deficiency

Keywords

Rheumatoid Arthritis; Vitamin B12 deficiency; Autoimmune Thyroid Disease; Autoantibodies

Outcome Measures

Primary Outcomes (1)

• 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.

  7 months

Secondary Outcomes (1)

• Presence of Anti-GPC Antibodies

  7 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keesler Air Force Base Medical Center: lead

Study Sites (1)

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Matthew B. Carroll, MD
• Organization: Keesler Medical Center

matthew.carroll.1@us.af.mil

228-376-3629

Study Officials

• Matthew B Carroll, MD

  Keesler Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Rheumatology

Study Record Dates

• First Submitted: June 9, 2013
• First Posted: June 12, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 29, 2015
• Results First Posted: May 29, 2015

Record last verified: 2015-05

Locations

US (1)