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 |
| Protocol serial number | - |
| Sponsor | University of Mostar, School of Medicine |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
Vukovarska 10 A
Mostar
88000
Bosnia and Herzegovina
 ORCID ID |
0000-0001-8486-3177 |
|---|---|
| Phone | +387 (0)63 321 386 |
| dragan.soldo3@tel.net.ba |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Concentration of n-3 fatty acids in total serum lipids, measured using gas chromatography at the end of pregnancy/delivery |
| Key secondary outcome measure(s) |
Weight of mother, measured by weighing scale at recruitment, 20th week of gestation, 30th week of gestation and before delivery |
| Completion date | 30/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 87 |
| 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
Mostar
88000
Bosnia and Herzegovina
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
