Effect of Armolipid on Lipid Profile in Children With Hypercholesterolemia
Condition: Dyslipidemias; Children, Only
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional

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.
    

Detailed description: 
      This is a prospective single center cohort study conducted at Outpatient Lipid Unit of 2nd
      Department of Pediatrics of the National and Kapodistrian University of Athens at the
      "Panagiotis & Aglaia Kyriakou" Children's Hospital in Greece. The study complies with the
      Declaration of Helsinki and the protocol was reviewed and approved by the appropriate ethical
      committee. Parental informed written consent was obtained prior to enrollment.

      Study population: Ninety children and adolescents, aged 7 to 16 years, with primary
      dyslipidemia.

      All participants had a positive family history for hypercholesterolemia (LDL > 95th
      percentile) and most of them had a positive family history for premature CVD (<55 years for
      males and <60 years for females) in first or/and second-degree relatives. Eleven of them had
      a genetically confirmed diagnosis of HeFH, while the rest had a probable or positive HeFH
      according to the Dutch Lipid Clinic Network criteria. None of them had moderate or
      significant hypertriglyceridemia, even those with increased body mass index (BMI).

      All children followed a low saturated fat and low cholesterol diet by a trained dietician and
      had moderate or intense physical activity, for at least 6 months before the participation in
      the study. In addition, during the last 6 months, 19 of them consumed 1.5 - 2.5g of plant
      sterols daily in the form of a yogurt drink or spread. Lifestyle and eating habits were
      maintained throughout the study.

      A nutraceutical containing five natural substances formulated as a tablet with the commercial
      name Armolipid (Rottapharm S.p.A., Monza, Italia), was recommended in all participants. Every
      tablet contained 200 mg red yeast rice (RYR) extract equivalent to 3 mg of monacolin K, 10 mg
      policosanols, 0.2 mg folic acid, 2.0 mg coenzyme Q10 and 0.5 mg astaxanthin, and was
      citrinin-free. It was administered once-daily with lunch.

      All participants as well as their parents were interviewed using a data collection form,
      created specifically for this research. Details concerning compliance to supplement intake,
      as well as possible adverse effects were recorded and analysed. Six out of 90 children were
      excluded from the study because they did not comply with the recommendation for taking the
      supplement (compliance rate 93.3%). All the rest 84 children had one and 64 of them had two
      evaluations under Armolipid treatment.

      Clinical and Labolatory evaluation: A clinical and laboratory evaluation of all participants
      took place right before (Time 0, T0) and once (n=84, Time 1, T1) or twice (n=64, T1 and Time
      2, T2) after the start of nutraceutical supplementation.

      The body weight (BW) in kg, the height (H) in cm were measured to the nearest 0.1 kg and 0.5
      cm, respectively (TANITA, Corporation Tokyo), with children barefoot and lightly dressed. BMI
      was calculated as BW in kg per H in m2. The standard deviation scores (z-scores) of BW, H and
      BMI were also calculated according to a standardized age- and sex- specific calculator. Waist
      circumference (WC) in cm was measured and the ratio of WC/Height was calculated. Systolic
      (SBP) and diastolic blood pressure (DBP) in mmHg were measured three consecutive times using
      an automated oscillometric device (Dinamap V100, GE Medical Systems Information Technologies)
      and the average value of the three measurements was used in the statistical analysis. The
      stage of puberty was recorded according to Tanner stages (I-V) for boys and girls.

      A full lipid profile including TC, LDL-C, high density lipoprotein - cholesterol (HDL-C),
      non-high density lipoprotein - cholesterol (non-HDL-C), triglycerides (TGs), apolipoprotein
      A1 (Apo-A1), apolipoprotein B (Apo-B), and lipoprotein (a) [Lp(a)] levels was evaluated in
      serum, after an overnight fast. Serum creatinine, glucose, aspartate and alanine
      aminotransferases (AST and ALT), creatine kinase (CK), and thyroid-stimulating hormone (TSH)
      were also assessed. A full blood count was performed in all participants.

      TC, HDL-C, LDL-C, TGs, glucose, ALT, AST, CK and creatinine were measured using an enzymatic
      method (Roche Diagnostics) on an automatic analyzer (Cobass Integra 800), and Apo-A1, Apo-B,
      and Lp(a) by an immunonephelometric assay (Siemens BNII Nephelometer Analyzer), with an
      intra-assay and inter-assay variation <5% for all tests. Non-HDL-C was measured as TC minus
      HDL-C. All lipid values are expressed in mg/dL. Haematological parameters (full blood count)
      were analyzed using the SysmexXE-2100 automated haematology analyzer (Roche Diagnostics). All
      tests were performed according to the manufacturers' instructions.

      At the time of the examination, all children were healthy and none of them had a febrile or
      afebrile infection in the two weeks preceding the check-up.
    

Intervention name(s): Effect of Armolipid on Lipid Profile in Children With Hypercholesterolemia
Intervention type(s): Dietary Supplement
Intervention description(s): A prospective single center cohort study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment