Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000107628
Ethics application status
Approved
Date submitted
14/01/2014
Date registered
29/01/2014
Date last updated
29/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral vitamin B12 supplementation after total gastrectomy due to gastric cancer
Scientific title
A study evaluating the clinical and laboratory efficacy of oral vitamin B12 supplementation in patients who underwent total gastrectomy due to gastric cancer
Secondary ID [1] 283898 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric cancer patients who underwent total gastrectomy 290888 0
Cobalamin deficiency 290889 0
Megaloblastic anemia and neurologic symptoms 290890 0
Iron deficiency anemia 290891 0
Condition category
Condition code
Cancer 291243 291243 0 0
Stomach
Diet and Nutrition 291358 291358 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Anemia is a frequent complication after gastrectomy due to deficiency of iron, vitamin B12 or folate, either alone or in combination. Vitamin B12 deficiency develops as a consequence of the decreased production of intrinsic factor which is essential for vitamin B12 absorption in the lower small bowel, and also because of a defect in the separation of vitamin B12 from its transporter protein. Vitamin B12 deficiency is a common cause of macrocytic anemia and has been implicated in a spectrum of neuropsychiatric disorders. To avoid that, parenteral iron treatment is recommended in these patients. However it is associated with high costs and patient discomfort, therefore, alternative ways of administration tend to be equated. Recently Kim Hyoung-Il showed that oral supplementation with vitamin B12 is an effective and safe treatment for vitamin B12 deficit in patients with gastric cancer who underwent total gastrectomy. Additionally, intramuscular vitamin B12 is no longer supplied in Portugal, being only available in hospital pharmacies. For this reason all gastrectomized patients are now treated with oral vitamin B12. This modification will certainly change the clinical practice in the management of gastrectomized patients since we consider that does not exist adequate clinical basis for the use of oral vitamin B12. In this context we consider this study appropriate in order to assess the clinical and laboratory efficacy of oral supplementation with vitamin B12 in gastrectomized patients due to gastric cancer, while others nutritional deficiencies are also assessed, such as iron deficiency and folate deficit, during a 2-year follow-up period. All patients will be treated with oral vitamin B12 (1000mg/day), 7 days post-operative. A patient diary will be used to monitor adherence to treatment.
Intervention code [1] 288576 0
Not applicable
Comparator / control treatment
Not apllicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291242 0
Measurement of serum vitamin B12 wiht laboratory tests every 3 months
Timepoint [1] 291242 0
Every 3 months during the follow up period (2 years)
Secondary outcome [1] 306320 0
To evaluate another nutritional deficits (iron and folate deficiency) with laboratory tests every 3 months
Timepoint [1] 306320 0
Every 3 months during the follow up period (2 years)

Eligibility
Key inclusion criteria
Adult patients who undergone total gastrectomy for gastric cancer; capacity of oral feeding; no oncologic active disease; capacity to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Incapacity to provide informed consent; metastatic disease

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5747 0
Portugal
State/province [1] 5747 0

Funding & Sponsors
Funding source category [1] 288540 0
Government body
Name [1] 288540 0
National Institute of Cancer of Lisbon
Country [1] 288540 0
Portugal
Primary sponsor type
Individual
Name
Joana Moleiro
Address
National Institute of Cancer of Lisbon
Gastroenterology department
Rua Professor Lima Basto, 1099-023 Lisboa
Country
Portugal
Secondary sponsor category [1] 287250 0
None
Name [1] 287250 0
Address [1] 287250 0
Country [1] 287250 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The deficit of vitamin B12, with subsequent development of megaboblastic anemia and neurological symptoms, emerges as one of the most common nutritional deficiencies after total gastrectomy. Therefore, parenteral vitamin B12 treatment is recommended in these patients. On the other hand, intramuscular forms of vitamin B12 are no longer available in Portugal, which will change the clinical management of these patients. This is an observational, prospective and uncontrolled study which aims to evaluate the clinical and laboratory efficacy of oral supplementation with vitamin B12 in patients undergoing total gastrectomy. Will be included all patients who underwent total gastrectomy for gastric adenocarcinoma without evidence of active malignant disease followed during a 2 years. All patients will receive daily oral vitamin B12 (dose: 1000mg/day). Several measurements (vitamin B12, iron and folates) will be measured every 3 months during the follow up period to investigate the efficacy and safety of oral vitamin B12 replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45514 0
Dr Joana Moleiro
Address 45514 0
IPO Lisboa - Servico de Gastrenterologia
Rua Professor Lima Basto, 1099-023 Lisboa
Portugal
Country 45514 0
Portugal
Phone 45514 0
+351911095262
Fax 45514 0
Email 45514 0
[email protected]
Contact person for public queries
Name 45515 0
Dr Susana Mao de Ferro
Address 45515 0
IPO Lisboa - Servico de Gastrenterologia
Rua Professor Lima Basto, 1099-023 Lisboa
Portugal
Country 45515 0
Portugal
Phone 45515 0
+351935924759
Fax 45515 0
Email 45515 0
[email protected]
Contact person for scientific queries
Name 45516 0
Dr A Dias Pereira
Address 45516 0
IPO Lisboa - Servico de Gastrenterologia
Rua Professor Lima Basto, 1099-023 Lisboa
Portugal
Country 45516 0
Portugal
Phone 45516 0
+351217200492
Fax 45516 0
Email 45516 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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