Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status (DHA-RICHOIL)

University of Milan

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Other: National Cholesterol Education Program (NCEP) Step I Diet; Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA); Dietary Supplement: Docosahexaenoic acid; Dietary Supplement: Germ oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00678067

DHA-RICH1

Details and patient eligibility

About

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

Full 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)

Enrollment: 36 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

12 hypercholesterolemic children 3-13 years of age

Treatment:

Dietary Supplement: Germ oil

Other: National Cholesterol Education Program (NCEP) Step I Diet

DHA+EPA group

Experimental group

Description:

12 hypercholesterolemic children 3-13 years of age

Treatment:

Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)

Other: National Cholesterol Education Program (NCEP) Step I Diet

DHA Group

Experimental group

Description:

12 hypercholesterolemic children 3-13 years of age

Treatment:

Dietary Supplement: Docosahexaenoic acid

Other: National Cholesterol Education Program (NCEP) Step I Diet