Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

Vitamin B12 Deficiency Clinical Trial

Official title:

Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699478
• Other study ID #: 4-2007-0460
• 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

• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

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