Neuroendocrine TumorNCT03143946
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
A study testing Vitamin supplement; and Diet advice in people with Neuroendocrine Tumor, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor
- What is being tested?
- Vitamin supplement; and Diet advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2016to Aug 2019
- 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
- Adult patients aged ≥ 18 years
- NET-patients with serotonin producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease
- Ability to comprehend Dutch (both reading and writing).
- Written informed consent provided.
- Use of somatostatin analogue for > 6 months.
Who cannot join
- Estimated life expectancy less than 6 months.
- Patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for ≥ 1 year.
- Major abdominal surgery during study period.
- Patients already participated in the DIVIT-pilot study
- Known hypersensitivity of (components of) somatostatin analogue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
Read the detailed description
Objective:
This study aims to investigate if the proportion of NET patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet.
Methods:
This is a single center 18-week open-label, non-comparative, single-arm, intervention study. After inclusion and the first measurements, adult patients with metastasized or irresectable NET will continue with four weeks of standard treatment. After these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
- Conditions
- Neuroendocrine Tumor
- Being tested
- Vitamin supplement;, Diet advice
- Keywords
- neuroendocrine tumor, vitamin, diet
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin supplement;Dietary supplement
Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12
Diet adviceOther
| Study group | Role | What they receive |
|---|---|---|
| Vitamin supplement and diet advice | Experimental | Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice Receives: Dietary Supplement: Vitamin supplement;; Other: Diet advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in the proportion of patients with normal vitamin values
the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine
Measured: 18 weeks
Secondary outcomes (5)
nutrition state
As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).
Measured: 18 weeks
distress
measured by the distress thermometer and problem list
Measured: 18 weeks
problems
as measured with the problem list.(the mean of each item)
Measured: 18 weeks
change in quality of life
determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30,
Measured: 18 weeks
difference in the self-reported healthy eating pattern.
as measured with a self-constructed scale
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start15 Dec 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemiek ME Walenkamp, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143946
- Sponsor's protocol ID
- 201600626
- Status last verified
- May 2024
- First submitted
- 11 Oct 2016
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
- ClinicalTrials.gov ID
- NCT03143946
- Acronym / sponsor ID
- 201600626
- Conditions
- Neuroendocrine Tumor
- Keywords
- neuroendocrine tumor, vitamin, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 8 May 2017 (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.
This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
Detailed description
Objective:
This study aims to investigate if the proportion of NET patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet.
Methods:
This is a single center 18-week open-label, non-comparative, single-arm, intervention study. After inclusion and the first measurements, adult patients with metastasized or irresectable NET will continue with four weeks of standard treatment. After these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. Effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. The measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin supplement and diet advice | Experimental | Dietary Supplement: Vitamin supplement;, Other: Diet adviceSingle arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged ≥ 18 years
- NET-patients with serotonin producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease
- Ability to comprehend Dutch (both reading and writing).
- Written informed consent provided.
- Use of somatostatin analogue for > 6 months.
Key exclusion criteria (5 listed)
- Estimated life expectancy less than 6 months.
- Patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for ≥ 1 year.
- Major abdominal surgery during study period.
- Patients already participated in the DIVIT-pilot study
- Known hypersensitivity of (components of) somatostatin analogue
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 |
|---|---|---|
| Vitamin supplement;Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12 | Dietary supplement | Vitamin supplement and diet advice |
| Diet advice | Other | Vitamin supplement and diet advice |
Primary outcome
the change in the proportion of patients with normal vitamin values
Time frame: 18 weeks
the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine
5 secondary outcomes
nutrition state
Time frame: 18 weeks
distress
Time frame: 18 weeks
problems
Time frame: 18 weeks
change in quality of life
Time frame: 18 weeks
difference in the self-reported healthy eating pattern.
Time frame: 18 weeks
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 6 May 2024.
- 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.
Annemiek ME Walenkamp, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin supplement; and Diet advice in people with Neuroendocrine Tumor, run by University Medical Center Groningen 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 5 inclusion and 5 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 6 May 2024. 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?
the change in the proportion of patients with normal vitamin values (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024; AzTrials last refreshed its copy on 4 Nov 2026.