NCT02371343

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

February 19, 2015

Last Update Submit

February 24, 2015

Conditions

Fetal MacrosomiaCongenital AbnormalityOther Respiratory Problems After Birth

Outcome Measures

Primary Outcomes (1)

  • Birth size

    Birth size of the newborns

    1 year

Secondary Outcomes (1)

  • Insulin like growth factor DNA methylation

    1 year

Study Arms (2)

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

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

Dietary Supplement: Sunflower Oil

Interventions

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

Fish-Oil
Sunflower OilDIETARY_SUPPLEMENT
Sunflower oil

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sami Ulus CH

Ankara, Ankara, 06120, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 24987679RESULT

  • Soulimane-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.

    PMID: 15898958RESULT

  • Dilli 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.

    PMID: 29460817DERIVED

MeSH Terms

Conditions

Fetal MacrosomiaCongenital Abnormalities

Interventions

Fish OilsSunflower Oil

Condition Hierarchy (Ancestors)

Diabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OilsLipidsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Dilek Dilli, Assoc Prof

    Teaching assistant

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Dilli, Assoc Prof

CONTACT

+905422368250dilekdilli2@yahoo.com

Nazan Doğan, MD

CONTACT

+903123055000nazanneslihan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dilek Dilli, MD

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

TU(1)