NCT00678067

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
Last Updated

May 19, 2008

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

May 8, 2008

Last Update Submit

May 16, 2008

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemic childrenDocosahexaenoic acidEicosapentaenoic acidBlood lipid profile

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (1)

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

    4 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

12 hypercholesterolemic children 3-13 years of age

Dietary Supplement: Germ oilOther: National Cholesterol Education Program (NCEP) Step I Diet

DHA+EPA group

EXPERIMENTAL

12 hypercholesterolemic children 3-13 years of age

Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)Other: National Cholesterol Education Program (NCEP) Step I Diet

DHA Group

EXPERIMENTAL

12 hypercholesterolemic children 3-13 years of age

Dietary Supplement: Docosahexaenoic acidOther: National Cholesterol Education Program (NCEP) Step I Diet

Interventions

Docosahexaenoic acidDIETARY_SUPPLEMENT

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

Also known as: DHA
DHA Group
Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)DIETARY_SUPPLEMENT

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

Also known as: DHA and EPA mixture
DHA+EPA group
Germ oilDIETARY_SUPPLEMENT

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

Also known as: wheat germ oil
Placebo
National Cholesterol Education Program (NCEP) Step I DietOTHER

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

Also known as: Dietary intervention, Dietary recommendations
DHA GroupDHA+EPA groupPlacebo

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary dyslipidemia
  • Obesity
  • Step I diet or any dietary supplement before entering the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24228803DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Docosahexaenoic Acidswheat germ oilDiet Therapy

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsNutrition TherapyTherapeutics

Study Officials

  • Silvia Decarlis, MD

    Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 15, 2008

Study Start

June 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

May 19, 2008

Record last verified: 2008-05