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Single arm. Patient be prescribed vitamin supplement if vitamin deficiencies are diagnosed and will get diet advice

Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12

Vitamin supplement;

Diet advice

Annemiek ME Walenkamp, MD, PhD

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.

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.

DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor

the change in the proportion of patients with normal vitamin values measured with quantitative analysis of blood and urine

As measured with the total score with Patient-Generated Subjective Global Assessment (PG/SGA).

measured by the distress thermometer and problem list

as measured with the problem list.(the mean of each item)

determined by the QLQ-GINET21 (a NET-specific EORTC quality of life questionnaire) and the cancer-specific EORTC QLQ-C30,

as measured with a self-constructed scale

University Medical Center Groningen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor	NCT03143946	Neuroendocrine ...	Vitamin supplem... Diet advice	18 Years -	University Medical Center Groningen
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor	NCT03143946	Neuroendocrine ...	Vitamin supplem... Diet advice	18 Years -	University Medical Center Groningen
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor	NCT03143946	Neuroendocrine ...	Vitamin supplem... Diet advice	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for diet advice

Every month we try and update this database with for diet advice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for diet advice

Every month we try and update this database with for diet advice cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for diet advice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.