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

ISRCTN	ISRCTN89549017
DOI	https://doi.org/10.1186/ISRCTN89549017
Secondary identifying numbers	Protocol v090907

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

Study design	Exploratory study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a Parental 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	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 study start date	01/10/2007
Completion date	31/08/2009

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	19 Years
Sex	Both
Target number of participants	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

Obsidian Research Ltd (UK)
Industry

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

Website	http://www.obsidianresearch.co.uk

Government

Welsh Assembly Government (UK) - SMART Technology Exploitation Programme

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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