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

Hypercholesterolemia Clinical Trial

— DHA-RICHOIL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678067
• Other study ID #: DHA-RICH1
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: May 16, 2008
• Start date: June 2005
• Est. completion date: November 2006

Study information

• Verified date: May 2008
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 13 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Docosahexaenoic acid
Soft capsules 500 mg/each; 1 capsule/day for 4 months
• Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)
Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention		4 months	No
Secondary	Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention		4 months	No