Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients

Completed

Conditions studied: Vitamin B12 Deficiency

In brief

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.

Key facts

Study ID

NCT01876329

Run by

Keesler Air Force Base Medical Center

People needed

125

Starts

2013-06-01

Expected to finish

2015-04-01

Last updated by the study team

2015-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Keesler Medical Center — Keesler Air Force Base, Mississippi, United States

Full record on ClinicalTrials.gov

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