Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03143946
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2016-10-11
Brief Title:
DIVIT Study Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Towards Optimal Personalized Diet and Vitamin Supplementation in Patients With a Neuroendocrine Tumor
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 t0 after 4 weeks t4 and after 18 weeks at end of study t18 Furthermore at t18 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 t0 after 4 weeks t4 and after 18 weeks at end of study t18 Furthermore at t18 a semi-qualitative interview will be performed
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 t0 after 4 weeks t4 and after 18 weeks at end of study t18 Furthermore at t18 a semi-qualitative interview will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None