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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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 12 hypercholesterolemic children 3-13 years of age |
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| DHA+EPA group | Experimental | 12 hypercholesterolemic children 3-13 years of age |
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| DHA Group | Experimental | 12 hypercholesterolemic children 3-13 years of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosahexaenoic acid | Dietary Supplement | Soft capsules 500 mg/each; 1 capsule/day for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Decarlis, MD | Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24228803 | Derived | 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. |
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| Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA) | Dietary Supplement | Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months |
|
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| Germ oil | Dietary Supplement | Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months |
|
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| National Cholesterol Education Program (NCEP) Step I Diet | 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 |
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|
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| C050055 | wheat germ oil |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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