Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
Primary Purpose
Vitamin B12 Deficiency
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mecobalamin
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin B12 Deficiency focused on measuring vitamin B12 deficiency, post total gastrectomy, stomach cancer
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)
Sites / Locations
- Yonsei university college of medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
post total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation
Outcomes
Primary Outcome Measures
Serum vitamin B12
Secondary Outcome Measures
Questionnaire
MCV
Serum Homocysteine
TIBC
Serum iron
Transferrin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00699478
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B12 Deficiency
Keywords
vitamin B12 deficiency, post total gastrectomy, stomach cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
post total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation
Intervention Type
Drug
Intervention Name(s)
mecobalamin
Other Intervention Name(s)
actinamide, cobalamin
Intervention Description
Methycobal Tab 0.5mg (contains 0.5 mg mecobalamin) for 3 times a day (Q8hrs) for three months
Primary Outcome Measure Information:
Title
Serum vitamin B12
Time Frame
1,2 and 3 months after administration of medicine
Secondary Outcome Measure Information:
Title
Questionnaire
Time Frame
1,2,3 months after administration of medicine
Title
MCV
Time Frame
1,2,3 months after administration of medicine
Title
Serum Homocysteine
Time Frame
1,2,3 months after administration of medicine
Title
TIBC
Time Frame
1,2,3 months after administration of medicine
Title
Serum iron
Time Frame
1,2,3 months after administration of medicine
Title
Transferrin
Time Frame
1,2,3 months after administration of medicine
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Jin Hyung, Ph.D
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei university college of medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
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.
Results Reference
background
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)
Results Reference
background
PubMed Identifier
11212437
Citation
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.
Results Reference
background
PubMed Identifier
12643357
Citation
Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1;67(5):979-86.
Results Reference
background
PubMed Identifier
10903597
Citation
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.
Results Reference
background
Citation
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)
Results Reference
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Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
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