The impact of n-3 fatty acids supplementation on the content of lipids in the pregnant women and the fetus

ISRCTN	ISRCTN36705743
DOI	https://doi.org/10.1186/ISRCTN36705743

Submission date: 25/10/2016
Registration date: 09/11/2016
Last edited: 27/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
For women who plan to become pregnant, it is important that they eat a healthy diet and are well nourished before they conceive. This is beneficial both for the mother and also the developing fetus. A healthy diet is important. This includes omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexenoic acid (DHA); these are thought to be critical for the baby’s brain and eye development. The aim of this research is to investigate whether taking omega-3 dietary supplements during pregnancy increases the amount found in the women’s blood and also the blood supplying the fetus.

Who can participate?
Women pregnant with one baby who are a healthy weight.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 take capsules containing 360 mg EPA (eicosapentanoic) and 240 mg DHA (docosahexanoic acid) every day during their pregnancy starting from the 14th week of gestation until delivery. Participants in group 2 do not take the supplements during pregnancy. At the time the baby is born, blood samples are taken from the mot er and also the umbilical cord to measure total fat (lipid) levels in the blood and also separated fat components, such as fatty acids, triacylglycerols and cholesterol.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Department of Obstetrics and Gynecology School of Medicine Mostar (Bosnia and Herzegovina)

When is the study starting and how long is it expected to run for?
May 2013 to November 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Soldo Dragan
dragan.soldo3@tel.net.ba

Contact information

Dr Soldo Dragan
Scientific

Vukovarska 10 A
Mostar
88000
Bosnia and Herzegovina

ORCID ID	0000-0001-8486-3177
Phone	+387 (0)63 321 386
Email	dragan.soldo3@tel.net.ba

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	The impact of EPA and DHA supplementation on the content of lipids in the pregnant women and the fetus
Study objectives	The aim of this research was to present the contents and the concentration of free fatty acids in the group of pregnant women which used the supplementation of n-3 fatty acids and the control group of pregnant women which did not use such supplementation of n-3 fatty acids.
Ethics approval(s)	Ethics Committee School of Medicine University of Mostar, 29/13/2013, ref. 2944/13
Health condition(s) or problem(s) studied	Pregnancy
Intervention	Participants are randomly allocated to one of two groups: 1. Intervention group: Participants take capsules containing 360 mg EPA (eicosapentanoic) and 240 mg DHA (docosahexanoic acid) per day during pregnancy, from baseline (14th week of gestation) until delivery. 2. Control group: Participants did not used the supplementation of n-3 fatty acids during pregnancy. Throughout the study, participants attend standard visits at Clinics. At delivery samples of blood from mother and umbilical cord are taken in order to measure levels of total lipids and separated lipid fractions: phospholipids, triacylglycerols, free fatty acids and cholesterol esters.
Intervention type	Supplement
Primary outcome measure	1. Concentration of n-3 fatty acids in total serum lipids, measured using gas chromatography at the end of pregnancy/delivery 2. Concentration of n-3 fatty acids in umbilical vein serum, measured using gas chromatography at time of birth 3. Concentration of monounsaturated fatty acids in serum total lipids of umbilical vein serum, measured by gas chromatography at time of birth 4. Concentration of monounsaturated fatty acids in serum total lipids of the mother's serum, measured by gas chromatography at the end of pregnancy
Secondary outcome measures	Weight of mother, measured by weighing scale at recruitment, 20th week of gestation, 30th week of gestation and before delivery
Overall study start date	24/05/2013
Completion date	30/11/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	87 individual participants
Total final enrolment	87
Key inclusion criteria	1. Healthy pregnant women 2. Single pregnancy 2. BMI ( < 25kg/m2) 3. Provision of informed consent
Key exclusion criteria	1. Pregnancy terminated as preterm delivery 2. Pregnant women with chronic illness 3. Pregnant women with gestational diabetes mellitus or preeclampsia
Date of first enrolment	13/06/2013
Date of final enrolment	30/11/2017

Locations

Countries of recruitment

Bosnia and Herzegovina

Study participating centre

Department of Obstetrics and Gynecology School of Medicine Mostar

Kralja Tvrtka, b.b.
Mostar
88000
Bosnia and Herzegovina

Sponsor information

University of Mostar, School of Medicine
University/education

Bijeli brijeg b.b.
Mostar
88000
Bosnia and Herzegovina

Phone	+387 36 335 600
Email	mefmo@sve-mo.ba
Website	http://mef.sve-mo.ba/
"ROR"	https://ror.org/00v89p354

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/11/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication of results data in a peer-reviewed journal.
IPD sharing plan	Please contact dragan.soldo3@tel.net.ba or josip.djelmis@zg.t-com.hr for access.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/02/2019	27/11/2020	Yes	No

Editorial Notes

27/11/2020: Publication reference and total final enrolment added.
05/01/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/05/2016 to 30/11/2017.
2. The overall trial end date was changed from 28/09/2016 to 30/11/2017.