Skip to main content
OpenTrials
Completed

NCT Number: NCT00678067

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docosahexaenoic acid

Dietary Supplement

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

Other names: DHA

Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)

Dietary Supplement

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

Other names: DHA and EPA mixture

Germ oil

Dietary Supplement

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

Other names: wheat germ oil

National Cholesterol Education Program (NCEP) Step I Diet

Other

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

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

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

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study 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

Acronym: DHA-RICHOIL

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 15, 2008
Registry last updated
May 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.