NCT00678067

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Docosahexaenoic acid	Soft capsules 500 mg/each; 1 capsule/day for 4 months
DIETARY_SUPPLEMENT	Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)	Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
DIETARY_SUPPLEMENT	Germ oil	Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months
OTHER	National Cholesterol Education Program (NCEP) Step I Diet	Dietary counselling aimed at achieving NCEP Dietary Guidelines: Total fat intake \<30% of total calories, Saturated fat intake \<10% of total calories, Polyunsaturated fat intake up to 10% of total calories, monounsaturated fat intake 10-15% of total calories

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2008-05-15
• Last updated: 2008-05-19