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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 9 March 2015
Main ID:  NCT02371343
Date of registration: 19/02/2015
Prospective Registration: Yes
Primary sponsor: Dr. Sami Ulus Children's Hospital
Public title: Fish Oil Supplementation in Women With Gestational Diabetes
Scientific title: Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
Date of first enrolment: March 2015
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT02371343
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Turkey
Contacts
Name:     Dilek Dilli, Assoc Prof
Address: 
Telephone: +905422368250
Email: dilekdilli2@yahoo.com
Affiliation: 
Name:     Dilek Dilli, Assoc Prof
Address: 
Telephone:
Email:
Affiliation:  Teaching assistant
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Congenital Abnormality
Fetal Macrosomia
Other Respiratory Problems After Birth
Intervention(s)
Dietary Supplement: Fish oil, Ocean plus
Dietary Supplement: Sunflower Oil
Primary Outcome(s)
Birth size [Time Frame: 1 year]
Secondary Outcome(s)
Insulin like growth factor DNA methylation [Time Frame: 1 year]
Secondary ID(s)
SamiUlusCH
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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