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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Docosahexaenoic acid
Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)
Germ oil
National Cholesterol Education Program (NCEP) Step I Diet
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemic children, Docosahexaenoic acid, Eicosapentaenoic acid, Blood lipid profile

Eligibility Criteria

3 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo

    DHA+EPA group

    DHA Group

    Arm Description

    12 hypercholesterolemic children 3-13 years of age

    12 hypercholesterolemic children 3-13 years of age

    12 hypercholesterolemic children 3-13 years of age

    Outcomes

    Primary Outcome Measures

    Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention

    Secondary Outcome Measures

    Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention

    Full Information

    First Posted
    May 8, 2008
    Last Updated
    May 16, 2008
    Sponsor
    University of Milan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00678067
    Brief Title
    Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status
    Acronym
    DHA-RICHOIL
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Milan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    Hypercholesterolemic children, Docosahexaenoic acid, Eicosapentaenoic acid, Blood lipid profile

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    12 hypercholesterolemic children 3-13 years of age
    Arm Title
    DHA+EPA group
    Arm Type
    Experimental
    Arm Description
    12 hypercholesterolemic children 3-13 years of age
    Arm Title
    DHA Group
    Arm Type
    Experimental
    Arm Description
    12 hypercholesterolemic children 3-13 years of age
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Docosahexaenoic acid
    Other Intervention Name(s)
    DHA
    Intervention Description
    Soft capsules 500 mg/each; 1 capsule/day for 4 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)
    Other Intervention Name(s)
    DHA and EPA mixture
    Intervention Description
    Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Germ oil
    Other Intervention Name(s)
    wheat germ oil
    Intervention Description
    Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months
    Intervention Type
    Other
    Intervention Name(s)
    National Cholesterol Education Program (NCEP) Step I Diet
    Other Intervention Name(s)
    Dietary intervention, Dietary recommendations
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Silvia Decarlis, MD
    Organizational Affiliation
    Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24228803
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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