vitamin deficiency
Conditions
Interventions
Two tailormade supplements for patients
one for that underwent esophagectomy
and one for (sub-)total gastrectomy.
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients >=18 years of age who underwent an esophagectomy or (sub-)total gastrectomy for malignancy with no signs of postoperative recurrence of disease.
Exclusion criteria
Exclusion criteria: - Patients that underwent a wedge resection of the stomach - Malignant disease recurrence - Metastases - Patients that are not capable to take supplementation due to altered mental status or swallow difficulties - No signed informed consent - Patients who are receiving chemotherapy - Patients with high vitamin status at baseline, except for vitamin b12
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is any deficiency (yes/no) defined as any of the below mentioned vitamins, minerals and proteins. The main study parameters are measurements of nutrient blood levels measured at baseline. and after 6, 12, 24 months supplementation to identify and resolve deficiencies, including: - Haemoglobin, haematocrit, MCV - Vitamins: B1, B6, B11, B12, A, D, E K - Methylmalonic acid when serum vitamin B12 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: -Albumin, total protein -C-reactive protein -Incidence of micronutrient deficiency post oesophageal or (sub-)total gastrectomy at baseline -Occurrence of exocrine pancreatic insufficieny (EPI) -Occurrence of the following symptoms: diarrhoea, steatorrhea, bloating which are all associated with EPI -QoL measured with questionnaires at baseline and after 6 months, 12 months and 24 months of supplementation -Vitality of patient at baseline and after 6 months, 12 months and 24 months of supplementation | — |
Countries
Netherlands
Outcome results
None listed