Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695937
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-01-13
Brief Title:
Brazilian Cardioprotective Diet Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia
Sponsor:
Hospital do Coracao
Organization:
Hospital do Coracao
Study Overview
Official Title:
Effect of the Adapted Brazilian Cardioprotective Diet Supplemented With Phytosterols andor Krill Oil in Patients With Familial Hypercholesterolemia DICA-HF Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
DICA-HF
Brief Summary:
The main objective of this pilot study is to evaluate the effects of the Brazilian Cardioprotective Diet DICA Br supplemented or not with phytosterols andor krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia FH identified by the Dutch Lipid Clinic Network Dutch MEDPED criteria In addition the following will be considered secondary objectives to perform participants complete sequencing of the exome to evaluate the effects of the interventions on lipid profile to identify subclasses of low-density lipoprotein LDL and high-density lipoprotein HDL cholesterol to perform untargeted lipidomic analyses to evaluate the frequency of mild moderate and severe adverse events according to study groups and to evaluate both implementation components and adherence rates to the protocol aiming to design a larger randomized trial In this pilot study between 48 and 76 individuals will be randomly enrolled into four groups 1 DICA Br adapted to FH DICA-HF phytosterol placebo krill oil placebo control group 2 DICA-HF 2gday of phytosterol krill oil placebo 3 DICA-HF phytosterol placebo 2gday of krill oil and 4 DICA-HF 2gday of phytosterol 2gday of krill oil Primary outcomes will be LDL-cholesterol for groups phytosterol vs placebo and lipoproteina for groups krill oil vs placebo after 120 days of follow up
World Health Organization Universal Trial Number WHO-UTN U1111-1296-7102
World Health Organization Universal Trial Number WHO-UTN U1111-1296-7102
Detailed Description:
DICA-HF pilot study is a superiority factorial and in parallel randomized placebo-controlled double-dummy clinical trial The randomization will be in blocks of varying sizes stratified by research center and the allocation ratio will be 1111 Participants will come from at least 9 center sites in different Brazilian geographic regions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None