NCT00699478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

June 13, 2008

Last Update Submit

July 18, 2012

Conditions

Vitamin B12 Deficiency

Keywords

vitamin B12 deficiencypost total gastrectomystomach cancer

Outcome Measures

Primary Outcomes (1)

  • Serum vitamin B12

    1,2 and 3 months after administration of medicine

Secondary Outcomes (6)

  • Questionnaire

    1,2,3 months after administration of medicine

  • MCV

    1,2,3 months after administration of medicine

  • Serum Homocysteine

    1,2,3 months after administration of medicine

  • TIBC

    1,2,3 months after administration of medicine

  • Serum iron

    1,2,3 months after administration of medicine

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

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

Drug: mecobalamin

Interventions

mecobalaminDRUG

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

Also known as: actinamide, cobalamin
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergone total gastrectomy for gastric cancer
  • Regular follow up is possible
  • Serum vit,. B12 \< 200pg/ml

You may not qualify if:

  • Has diseases other than stomach cancer
  • Patients with other kinds of oral supplementation (multi-vitamins)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei university college of medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (6)

  • 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.

    BACKGROUND

  • 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)

    BACKGROUND

  • 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.

    PMID: 11212437BACKGROUND

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

    PMID: 12643357BACKGROUND

  • 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.

    PMID: 10903597BACKGROUND

  • 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)

    BACKGROUND

MeSH Terms

Conditions

Vitamin B 12 DeficiencyStomach Neoplasms

Interventions

mecobalaminVitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Woo Jin Hyung, Ph.D

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations

KR(1)