The present study is designed with the aim of investigating the effect of selenium supplementation on glucose homeostasis in women with gestational diabetes mellitus (GDM). This is a prospective randomized, double blind Placebo-controlled, clinical trial. The study will be performed on pregnant women with GDM who are referred to outpatients clinic of Hafez hospital. Women will be randomly assigned to take either 200 µg selenium supplements as tablet or placebo daily for 12 weeks since 24 to 28 week of gestation. The primary outcomes are the glucose homeostasis changes including fasting plasma glucose (FPG), 2-h OGTT (oral glucose tolerance test), and HbA1C at initial and 3 months after intervention. In addition, we consider body mass index (BMI) as secondary outcomes. Finally, we will compare the results between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041933297N1
Registration date:2017-05-06, 1396/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Mina Rezvannia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3820 2362
Email address
rezvannia_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To survey the effects of selenium supplementation on glucose homeostasis in women with GDM referred to Hafez hospital
Public title
Effects of selenium supplementation on glucose homeostasis in women with GDM
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women diagnosed with gestational diabetes mellitus; Aged 18-40 years old. Exclusion criteria: Patients on oral hypoglycemic agents; Patients who received insulin.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
Approval date
2016-09-21, 1395/06/31
Ethics committee reference number
IR.SUMS.MED.REC.1395.13
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus in pregnancy
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Glucometer
2
Description
2 hours oral glucose tolerance test
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Glucometer
3
Description
Hemoglobin A1c
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Chromatographic
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before intervention - 3 months after intervention
Method of measurement
By BMI Formula
Intervention groups
1
Description
Intervention group: 200 µg selenium supplements daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: one placebo tablet daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz university of Medical Sciences
Full name of responsible person
Mina Rezvannia
Street address
Chamran Blvd, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University Of medical Science
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
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, Shiraz 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
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mina Rezvannia
Position
Resident of obstetrics and gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
rezvannia_m@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mina Rezvannia
Position
Resident of obstetrics and gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
rezvannia_m@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mina Rezvannia
Position
Resident of obstetrics and gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)