Vitamin B12 Deficiency Clinical Trial
Official title:
Presence of Autoantibodies to Gastric Parietal Cells and Subsequent Vitamin B12 Deficiency in Rheumatoid Arthritis Patients
Verified date | May 2015 |
Source | Keesler Air Force Base Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Keesler Medical Center | Keesler AFB | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Keesler Air Force Base Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Presence of Anti-GPC Antibodies | Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition. | 7 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02270749 -
Vitamin Deficiencies and Suppletion in Morbid Obesity
|
Phase 4 | |
Completed |
NCT02540642 -
Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
|
N/A | |
Completed |
NCT00826657 -
Vitamin B12 Supplementation Study
|
N/A | |
Completed |
NCT00843453 -
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly
|
N/A | |
Completed |
NCT01584050 -
Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate
|
N/A | |
Completed |
NCT01661309 -
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
|
N/A | |
Completed |
NCT01876732 -
Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
|
N/A | |
Active, not recruiting |
NCT00326833 -
How Many Patients Are in Need of Vitamin B12 Injections?
|
Phase 4 | |
Completed |
NCT00467623 -
Holotranscobalamin Remains Unchanged During Pregnancy
|
N/A | |
Completed |
NCT02076347 -
Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
|
N/A | |
Completed |
NCT01297361 -
The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
|
N/A | |
Completed |
NCT01136512 -
Metformin Use and Vitamin B12 Deficiency
|
N/A | |
Active, not recruiting |
NCT04048330 -
Periconceptional Surveillance in India
|
||
Completed |
NCT00699478 -
Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
|
Phase 2 | |
Completed |
NCT00279552 -
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
|
Phase 2 |