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

NCT00678067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-05-19

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Silvia Decarlis, MD · Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-11-30
Completion
2006-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678067 on ClinicalTrials.gov