Condition category
Pregnancy and Childbirth
Date applied
25/10/2016
Date assigned
09/11/2016
Last edited
05/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Soldo Dragan

ORCID ID

http://orcid.org/0000-0001-8486-3177

Contact details

Vukovarska 10 A
Mostar
88000
Bosnia and Herzegovina
+387 (0)63 321 386
dragan.soldo3@tel.net.ba

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

The impact of EPA and DHA supplementation on the content of lipids in the pregnant women and the fetus

Acronym

Study hypothesis

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

Ethics Committee School of Medicine University of Mostar, 29/13/2013, ref. 2944/13

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

24/05/2013

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy pregnant women
2. Single pregnancy
2. BMI ( < 25kg/m2)
3. Provision of informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

87 individual participants

Participant exclusion criteria

1. Pregnancy terminated as preterm delivery
2. Pregnant women with chronic illness
3. Pregnant women with gestational diabetes mellitus or preeclampsia

Recruitment start date

13/06/2013

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Bosnia and Herzegovina

Trial participating centre

Department of Obstetrics and Gynecology School of Medicine Mostar
Kralja Tvrtka, b.b.
Mostar
88000
Bosnia and Herzegovina

Sponsor information

Organisation

University of Mostar, School of Medicine

Sponsor details

Bijeli brijeg b.b.
Mostar
88000
Bosnia and Herzegovina
+387 36 335 600
mefmo@sve-mo.ba

Sponsor type

University/education

Website

http://mef.sve-mo.ba/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.