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OpenTrials
Completed

NCT Number: NCT05281380

VITAMin Insufficiency in Esophagogastric Neoplasms

Rationale: Esophageal cancer and gastric cancer are among the top ten most common cancers worldwide. Both diseases have major impact on the nutritional status of patients and their quality of life. Studies investigating post-operative nutritional status are limited and postoperative identification and treatment of micro- and macronutritional deficiencies are currently lacking in (inter-)national guidelines.

Objective: To identify and target vitamin deficiencies after surgery for esophagogastric neoplasms.

Study design: Single centre intervention study. Study population: Patients aged 18 years and older that underwent esophagectomy or (sub- )total gastrectomy for esophagogastric neoplasms.

Intervention (if applicable): Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Main study parameters/endpoints: Baseline micronutrient deficiency measurements and after 6, 12, 24 months supplementation,.

Secondary study parameters/ endpoints: Occurrence of exocrine pancreatic insufficiency (n,%), occurrence of diarrhoea (n,%), steatorrhea (n,%), bloating (n,%), time between surgery and start of supplementation (mean in months), quality of life experienced (questionnaires) at baseline and after 6, 12, 24 months supplementation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no health-related risks are present for participants due to the administration of supplementation that is already used as in clinical practice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZuyderlandMC

Sittard, Limburg, 6130MB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

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

Treatment and study plan

GIKAVI

Dietary Supplement

Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Primary outcomes

  1. Micronutrient deficiency yes or no.

    Time frame: 2 years

    Micronutrient deficiency yes or no.

Secondary outcomes

  1. The incidence of exocrine pancreatic insufficiency

    Time frame: 2 years

    Faecal elastase test

  2. To measure quality of life post-operative

    Time frame: 2 years

    Validated quality of life questionnaire

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Official study title

Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study

Acronym: VITAMIN

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2022
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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