The incidence risk of preeclampsia in pregnant women treated with selenium supplementation versus placebo: a randomized double-blind placebo-controlled trial
Objectives: To assess the incidence risk of preeclampsia in pregnant women treated with selenium supplementation versus placebo.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible pregnant women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Primigravid; first trimester.
Exclusion criteria: Using selenium supplementation during past year; using any medications except ferrous sulfate and folic acid; thyroid disease; diabetes; hypertension; infective diseases; diet full of selenium.
Intervention group: Selenium supplementation 100 mgr once a day until the end of pregnancy.
Control group: Placebo once a day until the end of pregnancy.
Primary outcome: Measuring systolic and diastolic blood pressure before intervention and at the end of pregnancy through physical examination.
Randomization: The patients will be randomly assigned to the intervention and control groups through drawing lot.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702109014N143
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The incidence risk of preeclampsia in pregnant women treated with selenium supplementation versus placebo: a randomized double-blind placebo-controlled trial
Public title
The incidence risk of preeclampsia in pregnant women treated with selenium supplementation versus placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primigravid; first trimester.
Exclusion criteria: Using selenium supplementation during past year; using any medications except ferrous sulfate and folic acid; thyroid disease; diabetes; hypertension; infective diseases; diet full of selenium.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
158
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to the intervention and control groups through drawing lot.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.UMSHA.REC.1395.362
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14.9
ICD-10 code description
Pre-eclampsia, unspecified
Primary outcomes
1
Description
Measuring systolic and diastolic blood pressure
Timepoint
before intervention and at the end of pregnancy
Method of measurement
through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Selenium supplementation 100 mgr once a day until the end of pregnancy.
Category
Treatment - Drugs
2
Description
Control group: Placebo once a day until the end of pregnancy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Fatemeh Mohsenpour
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Fatemeh Mohsenpour
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
fatemeh_mohsenpour450@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Fatemeh Mohsenpour
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
fatemeh_mohsenpour450@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)