CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 125 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01876329
NCT01876329N/ACompleted

Presence of Autoantibodies to Gastric Parietal Cells and Subsequent Vitamin B12 Deficiency in Rheumatoid Arthritis Patients

Keesler Air Force Base Medical Center·observational·Posted Jun 12, 2013·Updated May 29, 2015

In Brief

An observational study for Vitamin B12 Deficiency. Completed, enrolled 125 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 12, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.1 years ago