Vitamin B12 Deficiency Clinical Trial
Official title:
Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
Pernicious anemia develops in 50% of total gastrectomized due to gastric cancer patients.
Lack of intrinsic factor, which is secreted by parietal cell from stomach wall causes
deficiency of cobalamin, which, in final, causes pernicious anemia. Thus, patients who had
undergone total gastrectomy needs to be provided externally with cobalamin. Until now,
intramuscular injection of cyanocobalamin has been the choice of treatment for cobalamin
deficiency, but it has demerits in that it causes discomfort of coming to the hospital to
get an injection, and in its high costs.
However, in pernicious anemia in old age and absorption disorder patients, it has been
reported that oral administration of cobalamin had effect of elevating serum vitamin B12.
Thus, this study was designed to prove the effect of oral administration of vitamin B12 in
total gastrectomized patients with cobalamin deficiency.
Vitamin B 12 is important for hexane synthesis. Its deficiency causes pernicious anemia and
abnormal functioning neurons. It is not synthesized intrinsically, and extrinsic supplement
is vital. Vitamin B 12 is known to be abundant in meat and dairies. It is usually absorbed
in form of cobalamin and forms a complex with R binder, decomposed in duodenum, again form a
complex with intrinsic factor, and finally absorbed in terminal ileum.
In this process, intrinsic factor takes a major role, but when total gastrectomized,
absorption of cobalamin is impossible theoretically, because intrinsic factor is known to be
produced only from mucosa of the stomach. Thus,deficiency of vitamin B 12 develops, which
causes clinical symptoms of pernicious anemia and neurological disorders.
Total gastrectomy for cure of upper body cancer of stomach is gradually growing in Korea and
Japan, and more than 50% of the patients are reported to have deficiency of vitamin B12.
Pernicious anemia and irreversible neurologic disorder can develop, thus supplementing the
vitamin is an important treatment for the patient. However, the protocol in supplementation
has not been exhibited as yet.
Reported as now in Korea, after average six months postoperation, decrease of vitamin B12
was seen, and it is recommended that injection of Actinamide monthly after six months for
supplementation should be the protocol for total gastrectomized patient.
Intramuscular injection of Actinamide is the choice of treatment for vitamin B12 deficiency
for total gastrectomized patient. However, having to visit hospital and the high cost of
intramuscular vitamin B12 is a big burden for the patients. Van Walraven et al. from Canada
reported in 2001, that when comparing the cost for oral supplementation of vitamin B12 with
intramuscular injection, the difference of cost could rise up to 2 billion dollars. Oral
supplementation of vitamin B12 is simple to use, can lower the number of hospital visits,
and lessen the injection related complications, and thus improve the quality of life of the
patient and bring reduction of medical expense.
However, effect of oral supplementation of vitamin B12 has not been studied in Korea. In
Japan, Adachi et al. has reported that oral supplementation has effects on total
gastrectomized patients, although its mechanism was not known.
Studies on oral supplementation of vitamin B12 for total gastrectomized patient are rare,
thus this study was aimed to prove the effect of oral vitamin B12 in total gastrectomized
patients, and to establish a protocol for postoperation follow up.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
NCT01876329 -
Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients
|
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 |
NCT00279552 -
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
|
Phase 2 |