Clinical trial NCT00678067: Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status
Official title: Effects of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid(EPA)Supplementation on DHA Plasmatic Status and Blood Lipid Profile in Hypercholesterolemic Children in Addition to National Cholesterol Education Program Step I Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemic children
Docosahexaenoic acid
Eicosapentaenoic acid
Blood lipid profile
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine whether Docosahexaenoic Acid (DHA) and Docosahexaenoic + Eicosapentaenoic Acids (DHA+EPA) supplementation in addition to National Cholesterol Education Program Step I Diet in Hypercholesterolemic Children increases Docosahexaenoic Acid (DHA) plasma levels in the 2 intervention groups versus placebo. Secondary outcome measure: effect of DHA and DHA+EPA supplementation on blood lipid profile

Detailed description: In a double-blind placebo-controlled trial 36 hypercholesterolemic children, 3-13 years of age, 19 males and 17 females were put on National Cholesterol Education Program (NCEP)Step-I diet and randomised into 3 groups to receive 500 mg/day of purified Docosahexaenoic Acid (DHA), Docosahexaenoic Acid plus Eicosapentaenoic Acid (DHA+EPA) mixture (228 + 208 mg/day respectively), or wheat germ oil as placebo. They underwent at baseline and after a 4 month treatment: EPA and DHA levels in total plasma and in phospholipids, triglycerides, cholesteryl esters; dietary habits by food frequency questionnaire; blood lipid profile (total cholesterol, HDL cholesterol, triglycerides levels)

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary hypercholesterolemia (total cholesterol levels \> 200 mg/dl before entering the study)
* BMI \>3°and \< 97° percentile for age
* First referring to our Lipid Clinic

Exclusion Criteria:

* Secondary dyslipidemia
* Obesity
* Step I diet or any dietary supplement before entering the study

Primary outcomes:
measure: Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention
timeFrame: 4 months
Secondary outcomes:
measure: Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy
name: Silvia Decarlis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verduci E, Agostoni C, Radaelli G, Banderali G, Riva E, Giovannini M. Blood lipids profile in hyperlipidemic children undergoing different dietary long chain polyunsaturated supplementations: a preliminary clinical trial. Int J Food Sci Nutr. 2014 May;65(3):375-9. doi: 10.3109/09637486.2013.858239. Epub 2013 Nov 14.