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

NCT03143946 | Completed

• 1 other identifier: 201600626
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuroendocrine Tumor

Keywords

neuroendocrine tumor; vitamin; diet

Outcome Measures

Primary Outcomes (1)

• 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

  18 weeks

Secondary Outcomes (5)

• nutrition state

  18 weeks

• distress

  18 weeks

• problems

  18 weeks

• change in quality of life

  18 weeks

• difference in the self-reported healthy eating pattern.

  18 weeks

Study Arms (1)

Vitamin supplement and diet advice

EXPERIMENTAL

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

Dietary Supplement: Vitamin supplement;; Other: Diet advice

Interventions

Vitamin supplement; DIETARY_SUPPLEMENT

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

Vitamin supplement and diet advice

Diet advice OTHER

Vitamin supplement and diet advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Annemiek ME Walenkamp, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: May 8, 2017
• Study Start: December 15, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)