Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

• ClinicalTrials.gov Identifier: NCT00699478
• Recruitment Status: Completed
• First Posted: June 18, 2008
• Last Update Posted: July 19, 2012
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Woo Jin Hyung, Yonsei University

Tracking Information

• First Submitted Date: June 13, 2008
• First Posted Date: June 18, 2008
• Last Update Posted Date: July 19, 2012
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 7, 2008): Serum vitamin B12 [ Time Frame: 1,2 and 3 months after administration of medicine ]
• Original Primary Outcome Measures (submitted: June 13, 2008): serum vitamin B12 [ Time Frame: 1,2 and 3 months after administration of medicine ]

Current Secondary Outcome Measures (submitted: November 7, 2008)

• Questionnaire [ Time Frame: 1,2,3 months after administration of medicine ]
• MCV [ Time Frame: 1,2,3 months after administration of medicine ]
• Serum Homocysteine [ Time Frame: 1,2,3 months after administration of medicine ]
• TIBC [ Time Frame: 1,2,3 months after administration of medicine ]
• Serum iron [ Time Frame: 1,2,3 months after administration of medicine ]
• Transferrin [ Time Frame: 1,2,3 months after administration of medicine ]

Original Secondary Outcome Measures (submitted: June 13, 2008)

• Questionnaire [ Time Frame: 1,2,3 months after administration of medicine ]
• MCV [ Time Frame: 1,2,3 months after administration of medicine ]
• serum Homocysteine [ Time Frame: 1,2,3 months after administration of medicine ]
• TIBC [ Time Frame: 1,2,3 months after administration of medicine ]
• serum iron [ Time Frame: 1,2,3 months after administration of medicine ]
• transferrin [ Time Frame: 1,2,3 months after administration of medicine ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
• Official Title: Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Vitamin B12 Deficiency

Intervention

Drug: mecobalamin

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

Other Names:

• actinamide
• cobalamin

Study Arms

Experimental: 1

post total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation

Intervention: Drug: mecobalamin

Publications *

• 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.
• 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.
• Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1;67(5):979-86.
• 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. doi: 10.1097/00000658-200008000-00008.
• 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)

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2008): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00699478
• Other Study ID Numbers: 4-2007-0460
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Woo Jin Hyung, Yonsei University
• Original Responsible Party: Woo Jin Hyung, MD.PhD, Yonsei University Health System
• Current Study Sponsor: Yonsei University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Woo Jin Hyung, Ph.D; Yonsei University

• PRS Account: Yonsei University
• Verification Date: July 2012