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
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
-
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.