VITAMin Insufficiency in esophagogastric Neoplasms or the VITAMIN study
- Conditions
- Esophageal cancer and gastric cancer
- Registration Number
- NL-OMON25636
- Lead Sponsor
- GIKAVI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 248
A potential subject who meets any of the following criteria will be included for participation in this study:
- Patients =18 years of age who underwent an esophagectomy or (sub)total gastrectomy for malignancy with no signs of postoperative recurrence of disease.
- Written voluntary informed consent (IC).
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify which micronutrient deficiencies are most common after surgery for esophagogastric neoplasms and to observe the effect of supplementation.
- Secondary Outcome Measures
Name Time Method • The incidence of exocrine pancreatic insufficiency<br>• To prevent consequences of micronutrient deficiencies as iron-deficiency anemia,<br>rickets, folic acid anemia, disturbed vision, mental declination.<br>• To measure quality of life post-operative<br>• To measure quality of life regarding vitality post supplementation.