Objective: The aim of this study is to determine the effects of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 54 patients with GDM among pregnant women of eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 supplements (intervention group: n=27) or placebo (control group: n=27). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles, inflammatory factors and biomarkers of oxidative stress. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 4 months (May 10, 2014-August 10, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum hs-CRP levels, nitric oxide, plasma total antioxidant capacity (TAC), total glutathione (GSH) and malondialdehyde (MDA). Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406305623N20
Registration date:2014-07-16, 1393/04/25
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-07-16, 1393/04/25
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Science
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes
Public title
Effect of supplementation in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with preeclampsia; complete bed rest (CBR); intra uterine fetal death (IUFD); placenta abruption; preterm delivery.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak