Effect of Armolipid on Lipid Profile in Children With Hypercholesterolemia
Effect of a Nutraceutical, Containing Red Yeast Rice and Polycosanols (Armolipid), on Lipid Profile in Children With Moderate and Severe Hypercholesterolemia.
1 other identifier
interventional
90
1 country
1
Brief Summary
Data concerning the effectiveness od nutraceuticals in children with dyslipidemia are lacking. The aim of the present study was to evaluate the efficacy and safety of the long-term use of a dietary supplement containing red yeast rice (RYR), combined with other natural compounds, in children and adolescents with hypercholesterolemia. A nutraceutical, containing RYR, polycosanols, coenzyme Q10, astaxanthin and folic acid (commercial name: Armolipid), was administered once-daily in 84 children/adolescents with moderate or severe hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2022
CompletedFirst Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedSeptember 21, 2023
September 1, 2023
2.4 years
August 29, 2023
September 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Levels of LDL-C serum levels
LDL-C levels were evaluated in serum, after an overnight fast.
Laboratory evaluation before and 6 and 16 months after treatment
Secondary Outcomes (1)
Improvement of other than LDL-C parameters of lipid profile, as well as the evaluation of hepatic and muscle enzymes elevation.
Laboratory evaluation before and 6 and 16 months after treatment
Other Outcomes (5)
Waist Circumference (WC) and the ratio of WC/Height
Clinical evaluation before and 6 and 16 months after treatment
Systolic (SBP) and diastolic blood pressure (DBP)
Clinical evaluation before and 6 and 16 months after treatment
Body weight in kg
Clinical evaluation before and 6 and 16 months after treatment
- +2 more other outcomes
Study Arms (1)
Armolipid
EXPERIMENTALOne tablet of Armolipid (Rottapharm S.p.A., Monza, Italia), containing 200 mg red yeast rice, 10 mg policosanols, 0.2 mg folic acid, 2.0 mg coenzyme Q10 and 0.5 mg astaxanthin was administered once-daily with lunch. Clinical and laboratory evaluation took place before and 6 (IQR: 5-8) and 16 (IQR: 11-19.7) months after treatment.
Interventions
A prospective single center cohort study
Eligibility Criteria
You may qualify if:
- LDL-C \>150 mg/dl in more than two measurements, after therapeutic lifestyle changes for at least 6 months.
You may not qualify if:
- Secondary hypercholesterolemia
- Presence of any chronic disease or growth and developmental disorders
- Abnormal liver, kidney or thyroid function
- Prior use of hypolipidemic or other medication, at least 6 months before participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lipid Outpatient Unit, 2nd Department of Pediatrics, Medical School, National and Kapodistrian University of Athens (NKUA), "P. & A. Kyriakou" Children's Hospital
Athens, Greece
Related Publications (5)
Watts GF, Gidding SS, Hegele RA, Raal FJ, Sturm AC, Jones LK, Sarkies MN, Al-Rasadi K, Blom DJ, Daccord M, de Ferranti SD, Folco E, Libby P, Mata P, Nawawi HM, Ramaswami U, Ray KK, Stefanutti C, Yamashita S, Pang J, Thompson GR, Santos RD. International Atherosclerosis Society guidance for implementing best practice in the care of familial hypercholesterolaemia. Nat Rev Cardiol. 2023 Dec;20(12):845-869. doi: 10.1038/s41569-023-00892-0. Epub 2023 Jun 15.
PMID: 37322181BACKGROUNDSantini A, Novellino E. Nutraceuticals in hypercholesterolaemia: an overview. Br J Pharmacol. 2017 Jun;174(11):1450-1463. doi: 10.1111/bph.13636. Epub 2016 Oct 29.
PMID: 27685833BACKGROUNDCicero AFG, Fogacci F, Stoian AP, Vrablik M, Al Rasadi K, Banach M, Toth PP, Rizzo M. Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? Curr Atheroscler Rep. 2021 Aug 4;23(10):57. doi: 10.1007/s11883-021-00955-y.
PMID: 34345932BACKGROUNDCicero AFG, Kennedy C, Knezevic T, Bove M, Georges CMG, Satrauskiene A, Toth PP, Fogacci F. Efficacy and Safety of Armolipid Plus(R): An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials. Nutrients. 2021 Feb 16;13(2):638. doi: 10.3390/nu13020638.
PMID: 33669333BACKGROUNDGuardamagna O, Abello F, Baracco V, Stasiowska B, Martino F. The treatment of hypercholesterolemic children: efficacy and safety of a combination of red yeast rice extract and policosanols. Nutr Metab Cardiovasc Dis. 2011 Jun;21(6):424-9. doi: 10.1016/j.numecd.2009.10.015. Epub 2010 Feb 12.
PMID: 20153154BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Achilleas Attilakos, Assoc.Prof
Athens Children's Hospital Pan. and Aglaia Kyriakou
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. of Pediatrics
Study Record Dates
First Submitted
August 29, 2023
First Posted
September 21, 2023
Study Start
January 20, 2020
Primary Completion
June 25, 2022
Study Completion
September 5, 2022
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share