Esophageal CancerVITAMINNCT05281380
VITAMin Insufficiency in Esophagogastric Neoplasms
A study testing GIKAVI in people with Esophageal Cancer and Gastric Cancer, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Vitamin Disease
- What is being tested?
- GIKAVI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -
- 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
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- No signed informed consent
- Patients who are receiving chemotherapy
- Patients with high vitamin status at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
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.
Read more
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.
- Conditions
- Esophageal Cancer, Gastric Cancer, Vitamin Disease, Quality of Life
- Being tested
- GIKAVI
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIKAVIDietary supplement
Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with vitamin supplement | Other | Intervention with vitamin supplement Multi-E and Multi-G Receives: Dietary Supplement: GIKAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micronutrient deficiency yes or no.
Micronutrient deficiency yes or no.
Measured: 2 years
Secondary outcomes (2)
The incidence of exocrine pancreatic insufficiency
Faecal elastase test
Measured: 2 years
To measure quality of life post-operative
Validated quality of life questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Vijgen, MD,PhD, Principal investigator, Zuyderland MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281380
- Sponsor's protocol ID
- NL78919.096.21
- Acronym
- VITAMIN
- Status last verified
- Dec 2024
- First submitted
- 21 Oct 2021
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Velden AL, Vermeer TA, Boerma EG, Belgers EH, Stoot JH, Leers MP, Sosef MN, Vijgen GH. Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study. BMJ Open. 2023 Jul 4;13(7):e067981. doi: 10.1136/bmjopen-2022-067981.
PubMed 37407040
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT05281380
- Acronym / sponsor ID
- VITAMIN / NL78919.096.21
- Conditions
- Esophageal Cancer, Gastric Cancer, Vitamin Disease, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with vitamin supplement | Other | Dietary Supplement: GIKAVIIntervention with vitamin supplement Multi-E and Multi-G |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- -
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIKAVITwo tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy. | Dietary supplement | Intervention with vitamin supplement |
Primary outcome
Micronutrient deficiency yes or no.
Time frame: 2 years
Micronutrient deficiency yes or no.
2 secondary outcomes
The incidence of exocrine pancreatic insufficiency
Time frame: 2 years
To measure quality of life post-operative
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 37407040van der Velden AL, Vermeer TA, Boerma EG, Belgers EH, Stoot JH, Leers MP, Sosef MN, Vijgen GH. Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study. BMJ Open. 2023 Jul 4;13(7):e067981. doi: 10.1136/bmjopen-2022-067981.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Vijgen, MD,PhD principal investigator
Zuyderland MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIKAVI in people with Esophageal Cancer and Gastric Cancer, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micronutrient deficiency yes or no. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.