Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/11/2010
Date assigned
18/02/2011
Last edited
15/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zdenka Durackova

ORCID ID

Contact details

Institute of Medical Chemistry
Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
813 72
Slovakia
+421 (0)2 59357416
zdenka.durackova@fmed.uniba.sk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol v090907

Study information

Scientific title

The influence of daily nutritional supplementation with a product comprising a combination of omega-3 fish oils and phytosterols on the levels of blood lipids in hypercholesteremic children and adolescents

Acronym

Study hypothesis

Supplementation with omega-3 fish oil and phytosterols will favourably modulate lipid profile and some parameters of oxidative stress

Ethics approval

Ethics Board of Medical School, Comenius University in Bratislava approved on the 24th of September 2007

Study design

Exploratory study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a Parental information sheet

Condition

Hypercholesterolemia

Intervention

Daily administration of supplement comprising of omega-3 fish oil (1000mg EPA/DHA) and phytosterol esters (1300mg) for a period of 4 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Blood lipid profile
Blood samples were collected at weeks 0, 8 and 16 weeks.

Secondary outcome measures

1. Markers of oxidative stress
2. Antioxidant status
Blood samples were collected at weeks 0, 8 and 16 weeks.

Overall trial start date

01/10/2007

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parcipants of either sex, aged 12-19 years
2. Parental/guardian written informed consent and completed confidential health status to be obtained for all children participating

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Participants whose parents are unable/unwilling to give written informed consent
2. Participants who are not prepared to provide blood samples as required
3. Participants who are receiving lipid lowering drugs
4. Participants already involved in dietary control

Recruitment start date

01/10/2007

Recruitment end date

31/08/2009

Locations

Countries of recruitment

Slovakia

Trial participating centre

Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Bratislava
813 72
Slovakia

Sponsor information

Organisation

Obsidian Research Ltd (UK)

Sponsor details

c/o Dr Sue Plummer
Unit 2 Christchurch Road
Baglan Industrial Park
Port Talbot
SA12 7BZ
United Kingdom

Sponsor type

Industry

Website

http://www.obsidianresearch.co.uk

Funders

Funder type

Government

Funder name

Welsh Assembly Government (UK) - SMART Technology Exploitation Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23297818

Publication citations

  1. Results

    Garaiova I, Muchová J, Nagyová Z, Mišľanová C, Oravec S, Dukát A, Wang D, Plummer SF, Ďuračková Z, Effect of a plant sterol, fish oil and B vitamin combination on cardiovascular risk factors in hypercholesterolemic children and adolescents: a pilot study., Nutr J, 2013, 12, 7, doi: 10.1186/1475-2891-12-7.

Additional files

Editorial Notes