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NCT01876329 · ClinicalTrials.gov registry record

Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients

A clinical trial, sponsored by Keesler Air Force Base Medical Center.

Completed
Registry status
125
Enrollment target

NCT01876329: Completed study, sponsored by Keesler Air Force Base Medical Center.

NCT01876329 is a clinical trial that has completed, run by Keesler Air Force Base Medical Center. The registered enrollment target is 125 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01876329 has completed, sponsored by Keesler Air Force Base Medical Center.

COMPLETED
Registry status
125 participants
Enrollment target

Study 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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2013-06
Est. Completion 2015-04

What the finished NCT01876329 record still lists

NCT01876329 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01876329 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01876329 about?

NCT01876329 is a clinical study titled "Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients". 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 ...

What is the current status of trial NCT01876329?

This trial is currently completed. The enrollment target is 125 participants. The study started on 2013-06. Estimated completion is 2015-04.

Who is sponsoring clinical trial NCT01876329?

This trial is sponsored by Keesler Air Force Base Medical Center, which has 5 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01876329, the US trial registry maintained by the National Library of Medicine. NCT01876329 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.