VITAMin Insufficiency in esophagogastric Neoplasms
Completed
- Conditions
- vitamin deficiency1001797710017998
- Registration Number
- NL-OMON50515
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 248
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is any deficiency (yes/no) defined as any of the below<br /><br>mentioned vitamins, minerals and proteins.<br /><br><br /><br>The main study parameters are measurements of nutrient blood levels measured at<br /><br>baseline.<br /><br>and after 6, 12, 24 months supplementation to identify and resolve<br /><br>deficiencies, including:<br /><br>- Haemoglobin, haematocrit, MCV<br /><br>- Vitamins: B1, B6, B11, B12, A, D, E K<br /><br>- Methylmalonic acid when serum vitamin B12 < 350 pmol/L<br /><br>- Minerals: serum iron, calcium, zinc, magnesium<br /><br>- Parathyroid hormone<br /><br>- Proteins: ferritin/transferrin, Transferrin saturation percentage (TS%)<br /><br>- Creatinine<br /><br>- Phosphate</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are:<br /><br><br /><br>-Albumin, total protein<br /><br>-C-reactive protein<br /><br>-Incidence of micronutrient deficiency post oesophageal or (sub-)total<br /><br>gastrectomy at baseline<br /><br>-Occurrence of exocrine pancreatic insufficieny (EPI)<br /><br>-Occurrence of the following symptoms: diarrhoea, steatorrhea, bloating which<br /><br>are all associated with EPI<br /><br>-QoL measured with questionnaires at baseline and after 6 months, 12 months and<br /><br>24 months of supplementation<br /><br>-Vitality of patient at baseline and after 6 months, 12 months and 24 months of<br /><br>supplementation</p><br>