Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00699478
Other study ID # 4-2007-0460
Secondary ID
Status Completed
Phase Phase 2
First received June 13, 2008
Last updated July 18, 2012
Start date April 2008
Est. completion date November 2008

Study information

Verified date July 2012
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Undergone total gastrectomy for gastric cancer

- Regular follow up is possible

- Serum vit,. B12 < 200pg/ml

Exclusion Criteria:

- Has diseases other than stomach cancer

- Patients with other kinds of oral supplementation (multi-vitamins)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
mecobalamin
Methycobal Tab 0.5mg (contains 0.5 mg mecobalamin) for 3 times a day (Q8hrs) for three months

Locations

Country Name City State
Korea, Republic of Yonsei university college of medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Adachi S, Kawamoto T, Otsuka M, Todoroki T, Fukao K. Enteral vitamin B12 supplements reverse postgastrectomy B12 deficiency. Ann Surg. 2000 Aug;232(2):199-201. — View Citation

Bernard M, Babior H., Franklin Bunn. Megaloblastic anemias. In: Dennis LK, Anthony SF, Eugine B, Stephen LH, Dan LL, J.Larry J. editors. Harrison's Principles of internal medicine. 16th ed. New York: Mcgraw-Hill companies; 2005. p.601-7.

Hyun Dong Chae, Ki Ho Park. Vitamin B12 Deficiency after a Total Gastrectomy in Patients with Gastric Cancer. Korean Gastric Cancer Assoc 2006;6(1):6-10.(In Korean)

Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1;67(5):979-86. Review. — View Citation

Tai Il Seo, Sung Joon Kwon:A Study for Incidence and Treatment of Vitamin B12 Deficiency after Total Gastrectomy. J Korean Surg Soc 2003;64:206-11.(In Korean)

van Walraven C, Austin P, Naylor CD. Vitamin B12 injections versus oral supplements. How much money could be saved by switching from injections to pills? Can Fam Physician. 2001 Jan;47:79-86. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum vitamin B12 1,2 and 3 months after administration of medicine No
Secondary Questionnaire 1,2,3 months after administration of medicine No
Secondary MCV 1,2,3 months after administration of medicine No
Secondary Serum Homocysteine 1,2,3 months after administration of medicine No
Secondary TIBC 1,2,3 months after administration of medicine No
Secondary Serum iron 1,2,3 months after administration of medicine No
Secondary Transferrin 1,2,3 months after administration of medicine No
See also
  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