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

NCT ID: NCT00678067

Last Updated: 2008-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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

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Hypercholesterolemia

Keywords

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Hypercholesterolemic children Docosahexaenoic acid Eicosapentaenoic acid Blood lipid profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

12 hypercholesterolemic children 3-13 years of age

Group Type PLACEBO_COMPARATOR

Germ oil

Intervention Type DIETARY_SUPPLEMENT

Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months

National Cholesterol Education Program (NCEP) Step I Diet

Intervention Type OTHER

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

12 hypercholesterolemic children 3-13 years of age

Group Type EXPERIMENTAL

Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)

Intervention Type DIETARY_SUPPLEMENT

Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months

National Cholesterol Education Program (NCEP) Step I Diet

Intervention Type OTHER

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

12 hypercholesterolemic children 3-13 years of age

Group Type EXPERIMENTAL

Docosahexaenoic acid

Intervention Type DIETARY_SUPPLEMENT

Soft capsules 500 mg/each; 1 capsule/day for 4 months

National Cholesterol Education Program (NCEP) Step I Diet

Intervention Type OTHER

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

Interventions

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Docosahexaenoic acid

Soft capsules 500 mg/each; 1 capsule/day for 4 months

Intervention Type DIETARY_SUPPLEMENT

Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)

Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Other Intervention Names

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DHA DHA and EPA mixture wheat germ oil Dietary intervention Dietary recommendations

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Silvia Decarlis, MD

Role: PRINCIPAL_INVESTIGATOR

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

References

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Verduci E, Agostoni C, Radaelli G, Banderali G, Riva E, Giovannini M. Blood lipids profile in hyperlipidemic children undergoing different dietary long chain polyunsaturated supplementations: a preliminary clinical trial. Int J Food Sci Nutr. 2014 May;65(3):375-9. doi: 10.3109/09637486.2013.858239. Epub 2013 Nov 14.

Reference Type DERIVED
PMID: 24228803 (View on PubMed)

Other Identifiers

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DHA-RICH1

Identifier Type: -

Identifier Source: org_study_id