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

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00678067
First received: May 8, 2008
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention
Hypercholesterolemia
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

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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
12 hypercholesterolemic children 3-13 years of age
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 Name: wheat germ oil
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
Other Names:
  • Dietary intervention
  • Dietary recommendations
Experimental: DHA+EPA group
12 hypercholesterolemic children 3-13 years of age
Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)
Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
Other Name: DHA and EPA mixture
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
Other Names:
  • Dietary intervention
  • Dietary recommendations
Experimental: DHA Group
12 hypercholesterolemic children 3-13 years of age
Dietary Supplement: Docosahexaenoic acid
Soft capsules 500 mg/each; 1 capsule/day for 4 months
Other Name: DHA
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
Other Names:
  • Dietary intervention
  • Dietary recommendations

Detailed 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)

  Eligibility

Ages Eligible for Study:   3 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00678067

Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Silvia Decarlis, MD Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy
  More Information

No publications provided by University of Milan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Silvia Decarlis, MD, Dept. of Pediatrics, San Paolo Hospital, University of Milan, Italy
ClinicalTrials.gov Identifier: NCT00678067     History of Changes
Other Study ID Numbers: DHA-RICH1
Study First Received: May 8, 2008
Last Updated: May 16, 2008
Health Authority: Italy: National Bioethics Committee

Keywords provided by University of Milan:
Hypercholesterolemic children
Docosahexaenoic acid
Eicosapentaenoic acid
Blood lipid profile

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014