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VITAMin Insufficiency in esophagogastric Neoplasms or the VITAMIN study

Vitamin insufficiency after surgery for esophagogastric neoplasms: a prospective intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25636
Enrollment
248
Registered
2021-10-18
Start date
2021-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Esophageal cancer and gastric cancer

Interventions

Administriation of two tailormade supplements for patients
one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Sponsors

GIKAVI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To identify which micronutrient deficiencies are most common after surgery for esophagogastric neoplasms and to observe the effect of supplementation.

Secondary

MeasureTime frame
• The incidence of exocrine pancreatic insufficiency • To prevent consequences of micronutrient deficiencies as iron-deficiency anemia, rickets, folic acid anemia, disturbed vision, mental declination. • To measure quality of life post-operative • To measure quality of life regarding vitality post supplementation.

Contacts

Public ContactGuy Vijgen

Zuyderland Medisch Centrum

g.vijgen@zuyderland.nl0031618942736

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)