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

Phase 2
Not Enrolling
Vitamin B12 Deficiency

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Trial Information

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

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

Serum vitamin B12

Outcome Time Frame:

1,2 and 3 months after administration of medicine

Safety Issue:


Principal Investigator

Woo Jin Hyung, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University College of Medicine


South Korea: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

November 2008

Related Keywords:

  • Vitamin B12 Deficiency
  • vitamin B12 deficiency
  • post total gastrectomy
  • stomach cancer
  • Vitamin B 12 Deficiency