Clinical trial of the effect of combined omega-3 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles in patients with gestational diabetes
Objective: The aim of this study is to determine the effects of combined omega-3 fatty acids and vitamin D supplementation on metabolic profiles such as markers of insulin metabolism and lipid profiles in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 140 patients with gestational diabetes 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 combined omega-3 fatty acids and vitamin D (n=35), omega-3 fatty acids (n=35), vitamin D supplements (n=35) and placebo (n=35). Combined omega-3 fatty acids and vitamin D, omega-3 fatty acids, vitamin D supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles will be quantified at study baseline and at the end of the trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605135623N78
Registration date:2016-05-21, 1395/03/01
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-05-21, 1395/03/01
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
2016-03-05, 1394/12/15
Expected recruitment end date
2016-05-04, 1395/02/15
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 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles in patients with gestational diabetes
Public title
Effect of supplementation in treatment of patients with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with gestational diabetes in the age range of 18 to 40 years.
Exclusion criteria: Unwillingness to cooperate.
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:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics 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
2016-03-05, 1394/12/15
Ethics committee reference number
IR.ARAKMU.REC.1394.373
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
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Questionnaire
2
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
ELISA test
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: Combined 1000 mg omega-3 fatty acids (Barij Essence, Kashan, Iran) and 2000 IU vitamin D (Zahravi, Tabriz, Iran), twice a day, for 6 weeks orally.
Category
Treatment - Drugs
3
Description
Intervention group: 1000 mg omega-3 fatty acids (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
Category
Treatment - Drugs
4
Description
Intervention group: 2000 IU vitamin D (Zahravi, Tabriz, Iran), twice a day, 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
Emam Khomeyni Avenue, Arak
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)