Objective: The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on metabolic profiles in gestational diabetes. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion criteria: pregnant women aged 18-40 years old 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: 60 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, 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 after 6-wk intervention to measure metabolic profiles. Start and End Date of Intervention: 6 weeks. Outcomes: Fasting plasma glucose (FPG), serum insulin levels and lipid profiles will be measured at study baseline and end-of-trial
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506085623N43
Registration date:2015-06-23, 1394/04/02
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-06-23, 1394/04/02
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
Kashan University of Medical Science
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2015-06-14, 1394/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined omega-3 and vitamin E supplementation on metabolic profiles 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 old; 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
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
Kashan University of Medical Science
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
9434
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
4
Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
5
Description
HDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
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
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Science
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 Science
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, 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 Science
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
City
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)