Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Woo Jin Hyung, Yonsei University
ClinicalTrials.gov Identifier:
NCT00699478
First received: June 13, 2008
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Vitamin B12 Deficiency
Drug: mecobalamin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Serum vitamin B12 [ Time Frame: 1,2 and 3 months after administration of medicine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaire [ Time Frame: 1,2,3 months after administration of medicine ] [ Designated as safety issue: No ]
  • MCV [ Time Frame: 1,2,3 months after administration of medicine ] [ Designated as safety issue: No ]
  • Serum Homocysteine [ Time Frame: 1,2,3 months after administration of medicine ] [ Designated as safety issue: No ]
  • TIBC [ Time Frame: 1,2,3 months after administration of medicine ] [ Designated as safety issue: No ]
  • Serum iron [ Time Frame: 1,2,3 months after administration of medicine ] [ Designated as safety issue: No ]
  • Transferrin [ Time Frame: 1,2,3 months after administration of medicine ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
post total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation
Drug: mecobalamin
Methycobal Tab 0.5mg (contains 0.5 mg mecobalamin) for 3 times a day (Q8hrs) for three months
Other Names:
  • actinamide
  • cobalamin

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699478

Locations
Korea, Republic of
Yonsei university college of medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Woo Jin Hyung, Ph.D Yonsei University
  More Information

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)
Oh RC, Brown DL. Vitamin B12 Deficiency. Am Fam Physician 2003;67:979-86,993-4.
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)

Responsible Party: Woo Jin Hyung, Associate professor, Yonsei University
ClinicalTrials.gov Identifier: NCT00699478     History of Changes
Other Study ID Numbers: 4-2007-0460
Study First Received: June 13, 2008
Last Updated: July 18, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
vitamin B12 deficiency
post total gastrectomy
stomach cancer

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014