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
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

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 April 16, 2014