Fetal MacrosomiaNCT02371343
Fish Oil Supplementation in Women With Gestational Diabetes
A study testing Fish oil, Ocean plus and Sunflower Oil in people with Fetal Macrosomia and Congenital Abnormality, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Gestational diabetes is the development of diabetes during pregnancy. Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Macrosomia, Congenital Abnormality, Other Respiratory Problems After Birth
- What is being tested?
- Fish oil, Ocean plus and Sunflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who were diagnosed as gestational diabetes mellitus (GDM) between 24 and 28th week of pregnancy
- Women with GDM and accepted to be participate in the study
- Women younger that 40 years old
- The newborns of the women with GDM
Who cannot join
- The history of Type 1 diabetes melitus
- Abnormal glucose tolerance <20th gestational week
- The history of chronic illness in the mother
- Women who eat fish <2 times in a week
- Any history of sea-food allergy in the mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
Gestational diabetes is the development of diabetes during pregnancy. Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect women from two serious pregnancy complications -- gestational diabetes and preeclampsia. Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her developing baby every advantage in life starting in-utero. Recent studies suggested that the biologic processes underlying the observed associations may involve epigenetic changes, specifically DNA methylation. In this study the investigators aimed to examine the effect of fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and insulin like growth factor 1 DNA methylation.
Read the detailed description
Gestational diabetes is the development of diabetes during pregnancy. According to the National Institutes of Health, gestational diabetes occurs in about 5 percent of all pregnancies in the United States, resulting in about 200,000 cases a year. Treatment involves dietary measures, exercise and, in some cases, insulin injections. All pregnant women should be taking a prescribed pre-natal vitamin, and should also supplement with fish oil or another source of omega-3 fatty acids to help support the nervous system of their developing child.
Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. In diabetic pregnancies there is an increased risk of birth defects. Some evidence suggesting omega-3 fatty acids might help protect women from two serious pregnancy complications -- gestational diabetes and preeclampsia. Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her developing baby every advantage in life starting in-utero. In general the omega-3 fatty acids found in fish help the cardiovascular system, the brain (including moods), and even the brain and eyes of a developing baby. The risk of pre-term delivery and low birth weight is three and a half times higher when mothers are deficient in DHA. Recent studies suggested that the biologic processes underlying the observed associations may involve epigenetic changes, specifically DNA methylation. In this study the investigators aimed to examine the effect of fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and insulin like growth factor 1 DNA methylation.
- Being tested
- Fish oil, Ocean plus, Sunflower Oil
- Medical subject headings
- Fetal Macrosomia, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil, Ocean plusDietary supplement
Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, Germany
Sunflower OilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fish-Oil | Active comparator | The pregnants with gestational diabetes given fish oil:
(Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, German) During third trimester of pregnancy, Once in a day Receives: Dietary Supplement: Fish oil, Ocean plus |
| Sunflower oil | Placebo comparator | The pregnants with gestational diabetes given sunflower oil:
Sunflower oil capsules will be prepared in the pharmacy as the same size and colour with fish oil capsules During third trimester of pregnancy, Once in a day Receives: Dietary Supplement: Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth size
Birth size of the newborns
Measured: 1 year
Secondary outcomes (1)
Insulin like growth factor DNA methylation
Insulin like growth factor DNA methylation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fetal MacrosomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Dilek Dilli, Assoc Prof, Principal investigator, Teaching assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371343
- Sponsor's protocol ID
- SamiUlusCH
- Status last verified
- Feb 2015
- First submitted
- 19 Feb 2015
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Guermouche B, Soulimane-Mokhtari NA, Bouanane S, Merzouk H, Merzouk S, Narce M. Effect of dietary n - 3 polyunsaturated fatty acids on oxidant/antioxidant status in macrosomic offspring of diabetic rats. Biomed Res Int. 2014;2014:368107. doi: 10.1155/2014/368107. Epub 2014 Jun 2.
PubMed 24987679Soulimane-Mokhtari NA, Guermouche B, Yessoufou A, Saker M, Moutairou K, Hichami A, Merzouk H, Khan NA. Modulation of lipid metabolism by n-3 polyunsaturated fatty acids in gestational diabetic rats and their macrosomic offspring. Clin Sci (Lond). 2005 Sep;109(3):287-95. doi: 10.1042/CS20050028.
PubMed 15898958Dilli D, Dogan NN, Ipek MS, Cavus Y, Ceylaner S, Dogan H, Dursun A, Kucukozkan T, Zenciroglu A. MaFOS-GDM trial: Maternal fish oil supplementation in women with gestational diabetes and cord blood DNA methylation at insulin like growth factor-1 (IGF-1) gene. Clin Nutr ESPEN. 2018 Feb;23:73-78. doi: 10.1016/j.clnesp.2017.12.006. Epub 2017 Dec 30.
PubMed 29460817
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
- ClinicalTrials.gov ID
- NCT02371343
- Acronym / sponsor ID
- SamiUlusCH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gestational diabetes is the development of diabetes during pregnancy. Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect women from two serious pregnancy complications -- gestational diabetes and preeclampsia. Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her developing baby every advantage in life starting in-utero. Recent studies suggested that the biologic processes underlying the observed associations may involve epigenetic changes, specifically DNA methylation. In this study the investigators aimed to examine the effect of fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and insulin like growth factor 1 DNA methylation.
Detailed description
Gestational diabetes is the development of diabetes during pregnancy. According to the National Institutes of Health, gestational diabetes occurs in about 5 percent of all pregnancies in the United States, resulting in about 200,000 cases a year. Treatment involves dietary measures, exercise and, in some cases, insulin injections. All pregnant women should be taking a prescribed pre-natal vitamin, and should also supplement with fish oil or another source of omega-3 fatty acids to help support the nervous system of their developing child.
Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. In diabetic pregnancies there is an increased risk of birth defects. Some evidence suggesting omega-3 fatty acids might help protect women from two serious pregnancy complications -- gestational diabetes and preeclampsia. Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her developing baby every advantage in life starting in-utero. In general the omega-3 fatty acids found in fish help the cardiovascular system, the brain (including moods), and even the brain and eyes of a developing baby. The risk of pre-term delivery and low birth weight is three and a half times higher when mothers are deficient in DHA. Recent studies suggested that the biologic processes underlying the observed associations may involve epigenetic changes, specifically DNA methylation. In this study the investigators aimed to examine the effect of fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and insulin like growth factor 1 DNA methylation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish-Oil | Active comparator | Dietary Supplement: Fish oil, Ocean plusThe pregnants with gestational diabetes given fish oil: (Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, German) During third trimester of pregnancy, Once in a day |
| Sunflower oil | Placebo comparator | Dietary Supplement: Sunflower OilThe pregnants with gestational diabetes given sunflower oil: Sunflower oil capsules will be prepared in the pharmacy as the same size and colour with fish oil capsules During third trimester of pregnancy, Once in a day |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women who were diagnosed as gestational diabetes mellitus (GDM) between 24 and 28th week of pregnancy
- Women with GDM and accepted to be participate in the study
- Women younger that 40 years old
- The newborns of the women with GDM
Key exclusion criteria (5 listed)
- The history of Type 1 diabetes melitus
- Abnormal glucose tolerance <20th gestational week
- The history of chronic illness in the mother
- Women who eat fish <2 times in a week
- Any history of sea-food allergy in the mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil, Ocean plusOcean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, Germany | Dietary supplement | Fish-Oil |
| Sunflower Oil | Dietary supplement | Sunflower oil |
Primary outcome
Birth size
Time frame: 1 year
Birth size of the newborns
1 secondary outcome
Insulin like growth factor DNA methylation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Results publication: PubMed 24987679Guermouche B, Soulimane-Mokhtari NA, Bouanane S, Merzouk H, Merzouk S, Narce M. Effect of dietary n - 3 polyunsaturated fatty acids on oxidant/antioxidant status in macrosomic offspring of diabetic rats. Biomed Res Int. 2014;2014:368107. doi: 10.1155/2014/368107. Epub 2014 Jun 2.
- Results publication: PubMed 15898958Soulimane-Mokhtari NA, Guermouche B, Yessoufou A, Saker M, Moutairou K, Hichami A, Merzouk H, Khan NA. Modulation of lipid metabolism by n-3 polyunsaturated fatty acids in gestational diabetic rats and their macrosomic offspring. Clin Sci (Lond). 2005 Sep;109(3):287-95. doi: 10.1042/CS20050028.
- Derived from this study: PubMed 29460817Dilli D, Dogan NN, Ipek MS, Cavus Y, Ceylaner S, Dogan H, Dursun A, Kucukozkan T, Zenciroglu A. MaFOS-GDM trial: Maternal fish oil supplementation in women with gestational diabetes and cord blood DNA methylation at insulin like growth factor-1 (IGF-1) gene. Clin Nutr ESPEN. 2018 Feb;23:73-78. doi: 10.1016/j.clnesp.2017.12.006. Epub 2017 Dec 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Dilli, Assoc Prof principal investigator
Teaching assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil, Ocean plus and Sunflower Oil in people with Fetal Macrosomia and Congenital Abnormality, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Dilli, Assoc Prof (+905422368250, dilekdilli2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth size (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371343, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.