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

Not Applicable

Completed

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

• Registration Number: NCT00678067
• Lead Sponsor: University of Milan

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)

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-05
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Last Update Submitted: 2008-05-16
• Last Update Posted: 2008-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	National Cholesterol Education Program (NCEP) Step I Diet	12 hypercholesterolemic children 3-13 years of age
Placebo	Germ oil	12 hypercholesterolemic children 3-13 years of age
DHA+EPA group	Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)	12 hypercholesterolemic children 3-13 years of age
DHA+EPA group	National Cholesterol Education Program (NCEP) Step I Diet	12 hypercholesterolemic children 3-13 years of age
DHA Group	Docosahexaenoic acid	12 hypercholesterolemic children 3-13 years of age
DHA Group	National Cholesterol Education Program (NCEP) Step I Diet	12 hypercholesterolemic children 3-13 years of age

Primary Outcome Measures

Name	Time	Method
Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention	4 months

Secondary Outcome Measures

Name	Time	Method
Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention	4 months