Effects of fish oil and phytosterols on the lipid profile of children

ISRCTN	ISRCTN89549017
DOI	https://doi.org/10.1186/ISRCTN89549017
Protocol serial number	Protocol v090907
Sponsor	Obsidian Research Ltd (UK)
Funder	Welsh Assembly Government (UK) - SMART Technology Exploitation Programme

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Zdenka Durackova
Scientific

Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry
Medical School
Comenius University
Sasinkova 2
Bratislava
813 72
Slovakia

Phone	+421 (0)2 59357416
Email	zdenka.durackova@fmed.uniba.sk

Primary study design	Interventional
Study design	Exploratory study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Supplementation with omega-3 fish oil and phytosterols will favourably modulate lipid profile and some parameters of oxidative stress
Ethics approval(s)	Ethics Board of Medical School, Comenius University in Bratislava approved on the 24th of September 2007
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Blood lipid profile Blood samples were collected at weeks 0, 8 and 16 weeks.
Key secondary outcome measure(s)	1. Markers of oxidative stress 2. Antioxidant status Blood samples were collected at weeks 0, 8 and 16 weeks.
Completion date	31/08/2009

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	19 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	31/08/2009

Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry

Bratislava
813 72
Slovakia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/01/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes