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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00678067

Acronym

DHA-RICHOIL

Enrollment

Registered

2008-05-15

Start date

2005-06-30

Completion date

2006-11-30

Last updated

2008-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemic children, Docosahexaenoic acid, Eicosapentaenoic acid, Blood lipid profile

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)

Interventions

DIETARY_SUPPLEMENTDocosahexaenoic acid

Soft capsules 500 mg/each; 1 capsule/day for 4 months

DIETARY_SUPPLEMENTDocosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)

Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months

DIETARY_SUPPLEMENTGerm oil

Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months

OTHERNational 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 13 Years

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

Design outcomes

Primary

Measure	Time frame
Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention	4 months

Secondary

Measure	Time frame
Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention	4 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026