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Fish Oil Supplementation in Women With Gestational Diabetes

Primary Purpose

Fetal Macrosomia, Congenital Abnormality, Other Respiratory Problems After Birth

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fish oil, Ocean plus
Sunflower Oil
Sponsored by
Dr. Sami Ulus Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Macrosomia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sami Ulus CH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fish-Oil

Sunflower oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Birth size
Birth size of the newborns

Secondary Outcome Measures

Insulin like growth factor DNA methylation
Insulin like growth factor DNA methylation

Full Information

First Posted
February 19, 2015
Last Updated
February 24, 2015
Sponsor
Dr. Sami Ulus Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02371343
Brief Title
Fish Oil Supplementation in Women With Gestational Diabetes
Official Title
Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Macrosomia, Congenital Abnormality, Other Respiratory Problems After Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fish-Oil
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sunflower oil
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil, Ocean plus
Intervention Description
Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, Germany
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower Oil
Primary Outcome Measure Information:
Title
Birth size
Description
Birth size of the newborns
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Insulin like growth factor DNA methylation
Description
Insulin like growth factor DNA methylation
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Dilli, Assoc Prof
Phone
+905422368250
Email
dilekdilli2@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nazan Doğan, MD
Phone
+903123055000
Ext
6284
Email
nazanneslihan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Dilli, Assoc Prof
Organizational Affiliation
Teaching assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sami Ulus CH
City
Ankara
ZIP/Postal Code
06120
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24987679
Citation
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.
Results Reference
result
PubMed Identifier
15898958
Citation
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.
Results Reference
result
PubMed Identifier
29460817
Citation
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.
Results Reference
derived

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Fish Oil Supplementation in Women With Gestational Diabetes

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