Vitamin B12 DeficiencyPhase 2NCT00699478
Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
A Phase 2 study testing mecobalamin in people with Vitamin B12 Deficiency, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- mecobalamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergone total gastrectomy for gastric cancer
- Regular follow up is possible
- Serum vit,. B12 < 200pg/ml
Who cannot join
- Has diseases other than stomach cancer
- Patients with other kinds of oral supplementation (multi-vitamins)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei university college of medicine
Seoul, Seoul, 120-752
About this study
Official title: Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
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.
Read the 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.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- mecobalamin
- Keywords
- vitamin B12 deficiency, post total gastrectomy, stomach cancer
- Medical subject headings
- Vitamin B 12 Deficiency, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mecobalaminDrug
Also called actinamide, cobalamin
Methycobal Tab 0.5mg (contains 0.5 mg mecobalamin) for 3 times a day (Q8hrs) for three months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | post total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation Receives: Drug: mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin B12
Measured: 1,2 and 3 months after administration of medicine
Secondary outcomes (6)
Questionnaire
Measured: 1,2,3 months after administration of medicine
MCV
Measured: 1,2,3 months after administration of medicine
Serum Homocysteine
Measured: 1,2,3 months after administration of medicine
TIBC
Measured: 1,2,3 months after administration of medicine
Serum iron
Measured: 1,2,3 months after administration of medicine
Transferrin
Measured: 1,2,3 months after administration of medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Jin Hyung, Yonsei University
- Investigators
- Woo Jin Hyung, Ph.D, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699478
- Sponsor's protocol ID
- 4-2007-0460
- Status last verified
- Jul 2012
- First submitted
- 13 Jun 2008
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11212437Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1;67(5):979-86.
PubMed 12643357Adachi 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.
PubMed 10903597Hyun 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)
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
- ClinicalTrials.gov ID
- NCT00699478
- Acronym / sponsor ID
- 4-2007-0460
- Conditions
- Vitamin B12 Deficiency
- Keywords
- vitamin B12 deficiency, post total gastrectomy, stomach cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mecobalaminpost total gastrectomized patients due to gastric cancer who has vitamin B12 deficiency - given oral vitamin B 12 supplementation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Undergone total gastrectomy for gastric cancer
- Regular follow up is possible
- Serum vit,. B12 < 200pg/ml
Key exclusion criteria (2 listed)
- Has diseases other than stomach cancer
- Patients with other kinds of oral supplementation (multi-vitamins)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mecobalaminAlso: actinamide, cobalaminMethycobal Tab 0.5mg (contains 0.5 mg mecobalamin) for 3 times a day (Q8hrs) for three months | Drug | 1 |
Primary outcome
Serum vitamin B12
Time frame: 1,2 and 3 months after administration of medicine
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- BackgroundBernard 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.
- BackgroundTai 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: PubMed 11212437van 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.
- Background: PubMed 12643357Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003 Mar 1;67(5):979-86.
- Background: PubMed 10903597Adachi 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.
- BackgroundHyun 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Jin Hyung, Ph.D principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mecobalamin in people with Vitamin B12 Deficiency, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum vitamin B12 (time frame: 1,2 and 3 months after administration of medicine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699478, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.