Objective: The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. 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: 60 patients with GDM among pregnant women of eligible and referred to Kosar 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 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and 6 weeks after intervention to measure 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: 6 weeks (July 27, 2015-September 11, 2015). Outcomes: Biomarkers of oxidative stress will be measured at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507035623N47
Registration date:2015-07-19, 1394/04/28
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-07-19, 1394/04/28
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
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-07-13, 1394/04/22
Expected recruitment end date
2015-07-27, 1394/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined omega-3 and vitamin E supplementation on 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 week gestation.
Exclusion criteria: The use of substitute treatments including hormone or vitamin supplements; patients with pre-eclampsia; 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
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethicc's committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.ARAKMU.REC.1394.37
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
4
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
5
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
6
Description
Newborns' weight
Timepoint
The first 24 h after birth
Method of measurement
Scale
7
Description
Newborn length
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape
8
Description
Newborn head circumference
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape
9
Description
Polyhydramnios
Timepoint
Post-intervention
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combined omega-3 and vitamin E pearl, 1000 mg omega-3 and 400 IU vitamin E, daily, for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo pearl, daily, for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir-asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir-asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)