Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status (DHA-RICHOIL)
May 16, 2008 updated by: University of Milan
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
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
Study Overview
Status
Completed
Conditions
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)
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 13 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
12 hypercholesterolemic children 3-13 years of age
|
Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months
Other Names:
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:
|
|
Experimental: DHA+EPA group
12 hypercholesterolemic children 3-13 years of age
|
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:
Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
Other Names:
|
|
Experimental: DHA Group
12 hypercholesterolemic children 3-13 years of age
|
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:
Soft capsules 500 mg/each; 1 capsule/day for 4 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia Decarlis, MD, Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
May 8, 2008
First Submitted That Met QC Criteria
May 14, 2008
First Posted (Estimate)
May 15, 2008
Study Record Updates
Last Update Posted (Estimate)
May 19, 2008
Last Update Submitted That Met QC Criteria
May 16, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHA-RICH1
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