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Oral vitamin B12 supplementation after total gastrectomy due to gastric cancer

A study evaluating the clinical and laboratory efficacy of oral vitamin B12 supplementation in patients who underwent total gastrectomy due to gastric cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000107628
Enrollment
30
Registered
2014-01-29
Start date
2014-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ne

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.

Sponsors

Joana Moleiro
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients who undergone total gastrectomy for gastric cancer; capacity of oral feeding; no oncologic active disease; capacity to provide informed consent

Exclusion criteria

Incapacity to provide informed consent; metastatic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026