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Effects of fish oil and phytosterols on the lipid profile of children
ISRCTN ISRCTN89549017
DOI 10.1186/ISRCTN89549017
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of fish oil and phytosterols on the lipid profile of children
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 N/A
Serial number at source Protocol v090907
Study hypothesis Supplementation with omega-3 fish oil and phytosterols will favourably modulate lipid profile and some parameters of oxidative stress
Lay summary Not provided at time of registration
Ethics approval Ethics Board of Medical School, Comenius University in Bratislava approved on the 24th of September 2007
Study design Exploratory study
Countries of recruitment Slovakia
Disease/condition/study domain Hypercholesterolemia
Participants - 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
Participants - 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
Anticipated start date 01/10/2007
Anticipated end date 31/08/2009
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a Parental information sheet
Target number of participants 30
Interventions Daily administration of supplement comprising of omega-3 fish oil (1000mg EPA/DHA) and phytosterol esters (1300mg) for a period of 4 months
Primary outcome measure(s) Blood lipid profile
Blood samples were collected at weeks 0, 8 and 16 weeks.
Secondary outcome measure(s) 1. Markers of oxidative stress
2. Antioxidant status
Blood samples were collected at weeks 0, 8 and 16 weeks.
Sources of funding Welsh Assembly Government (UK) - SMART Technology Exploitation Programme
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23297818
Contact name Prof  Zdenka  Durackova
  Address Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
  City/town Bratislava
  Zip/Postcode 813 72
  Country Slovakia
  Tel +421 (0)2 59357416
  Fax +421 (0)2 59357557
  Email zdenka.durackova@fmed.uniba.sk
Sponsor Obsidian Research Ltd (UK)
  Address c/o Dr Sue Plummer
Unit 2 Christchurch Road
Baglan Industrial Park
  City/town Port Talbot
  Zip/Postcode SA12 7BZ
  Country United Kingdom
  Sponsor website: http://www.obsidianresearch.co.uk
Date applied 11/11/2010
Last edited 15/07/2013
Date ISRCTN assigned 18/02/2011
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