N/A
N=125
Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients
Vitamin B12 Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01876329 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Prevalence of Vitamin B12 Deficiency — 3; 6; 4 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Keesler Air Force Base Medical Center
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Vitamin B12 Deficiency |
3; 6; 4 | — |
| SECONDARY Presence of Anti-GPC Antibodies |
7; 4; 8 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01876329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.