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

Study Overview
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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)

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>12 hypercholesterolemic children 3-13 years of age | Dietary Supplement: Germ oil<br>* Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months<br>* Other names: wheat germ oil;Other: National Cholesterol Education Program (NCEP) Step I Diet<br>* 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<br>* Other names: Dietary recommendations;|
| Experimental: DHA+EPA group<br>12 hypercholesterolemic children 3-13 years of age | Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)<br>* Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months<br>* Other names: DHA and EPA mixture;Other: National Cholesterol Education Program (NCEP) Step I Diet<br>* 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<br>* Other names: Dietary recommendations;|
| Experimental: DHA Group<br>12 hypercholesterolemic children 3-13 years of age | Dietary Supplement: Docosahexaenoic acid<br>* Soft capsules 500 mg/each; 1 capsule/day for 4 months<br>* Other names: DHA;Other: National Cholesterol Education Program (NCEP) Step I Diet<br>* 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<br>* Other names: Dietary recommendations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercholesterolemic children, Docosahexaenoic acid, Eicosapentaenoic acid, Blood lipid profile