HypercholesterolemiaDHA-RICHOILNCT00678067
Effects of Docosahexaenoic and Eicosapentaenoic Acids in Hypercholesterolemic Children Plus Diet on Docosahexaenoic Acid (DHA) Status
A study testing Docosahexaenoic acid, Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA) and Germ oil in people with Hypercholesterolemia, run by University of Milan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Docosahexaenoic acid, Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA) and Germ oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Secondary dyslipidemia
- Obesity
- Step I diet or any dietary supplement before entering the study
About this study
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
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
Read the 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)
- Conditions
- Hypercholesterolemia
- Being tested
- Docosahexaenoic acid, Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA), Germ oil, National Cholesterol Education Program (NCEP) Step I Diet
- Keywords
- Hypercholesterolemic children, Docosahexaenoic acid, Eicosapentaenoic acid, Blood lipid profile
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acidDietary supplement
Also called DHA
Soft capsules 500 mg/each; 1 capsule/day for 4 months
Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)Dietary supplement
Also called DHA and EPA mixture
Soft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months
Germ oilDietary supplement
Also called wheat germ oil
Soft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months
National Cholesterol Education Program (NCEP) Step I DietOther
Also called Dietary intervention, Dietary recommendations
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 12 hypercholesterolemic children 3-13 years of age Receives: Dietary Supplement: Germ oil; Other: National Cholesterol Education Program (NCEP) Step I Diet |
| DHA+EPA group | Experimental | 12 hypercholesterolemic children 3-13 years of age Receives: 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 Receives: Dietary Supplement: Docosahexaenoic acid; Other: National Cholesterol Education Program (NCEP) Step I Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention
Measured: 4 months
Secondary outcomes (1)
Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Silvia Decarlis, MD, Principal investigator, Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678067
- Sponsor's protocol ID
- DHA-RICH1
- Acronym
- DHA-RICHOIL
- Status last verified
- May 2008
- First submitted
- 8 May 2008
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24228803
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00678067
- Acronym / sponsor ID
- DHA-RICHOIL / DHA-RICH1
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemic children, Docosahexaenoic acid, Eicosapentaenoic acid, Blood lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Germ oil, Other: National Cholesterol Education Program (NCEP) Step I Diet12 hypercholesterolemic children 3-13 years of age |
| DHA+EPA group | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA), Other: National Cholesterol Education Program (NCEP) Step I Diet12 hypercholesterolemic children 3-13 years of age |
| DHA Group | Experimental | Dietary Supplement: Docosahexaenoic acid, Other: National Cholesterol Education Program (NCEP) Step I Diet12 hypercholesterolemic children 3-13 years of age |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Secondary dyslipidemia
- Obesity
- Step I diet or any dietary supplement before entering the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic acidAlso: DHASoft capsules 500 mg/each; 1 capsule/day for 4 months | Dietary supplement | DHA Group |
| Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA)Also: DHA and EPA mixtureSoft capsules, 228 mg DHA + 208 mg EPA /each; 1 capsule/day for 4 months | Dietary supplement | DHA+EPA group |
| Germ oilAlso: wheat germ oilSoft capsules, 275 mg linoleic acid + 35 mg linolenic acid + 65 mg oleic acid /each; 1 capsule/day for 4 months | Dietary supplement | Placebo |
| National Cholesterol Education Program (NCEP) Step I DietAlso: Dietary intervention, Dietary recommendationsDietary 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 | DHA Group, DHA+EPA group, Placebo |
Primary outcome
Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention
Time frame: 4 months
1 secondary outcome
Blood lipid profile variation in DHA Group and DHA+EPA Group versus placebo group after intervention
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2008.
- Derived from this study: PubMed 24228803Verduci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Decarlis, MD principal investigator
Dept. of Pediatrics, San paolo Hospital, University of Milan, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic acid, Docosahexaenoic acid (DHA)+ Eicosapentaenoic acid (EPA) and Germ oil in people with Hypercholesterolemia, run by University of Milan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Docosahexaenoic Acid (DHA) levels in DHA group and DHA+EPA group versus placebo after intervention (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2008.