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

Sponsored by:	University of Milan
Information provided by:	University of Milan
ClinicalTrials.gov Identifier:	NCT00678067

Purpose

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

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Dietary Supplements

Drug Information available for: Cholest-5-en-3-ol (3beta)- Lipids Docosahexaenoic acids Eicosapentaenoic acid Oleic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of Milan:

Primary Outcome Measures:

Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	June 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator 12 hypercholesterolemic children 3-13 years of age	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
DHA+EPA group: Experimental 12 hypercholesterolemic children 3-13 years of age	Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA) Soft capsules, 228 mg DHA + 208 mg EPA /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
DHA Group: Experimental 12 hypercholesterolemic children 3-13 years of age	Dietary Supplement: Docosahexaenoic acid Soft capsules 500 mg/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

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

Ages Eligible for Study:	3 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678067

Sponsors and Collaborators

University of Milan

Investigators

Principal Investigator:

Silvia Decarlis, MD

Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy

More Information

Responsible Party:	Dept. of Pediatrics, San Paolo Hospital, University of Milan, Italy ( Silvia Decarlis, MD )
Study ID Numbers:	DHA-RICH1
Study First Received:	May 8, 2008
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00678067
Health Authority:	Italy: National Bioethics Committee

Keywords provided by University of Milan:

Hypercholesterolemic children
Docosahexaenoic acid
Eicosapentaenoic acid
Blood lipid profile

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009