The effect of Selenium supplementation on clinical outcomes of Preeclampsia, metabolic profiles, and Pulsatility Index (PI ) of uterine artery in Doppler sonography in high risk mothers screening with Quadruple tests
Determining the Complementary Effect of Selenium on clinical outcomes of Preeclampsia, metabolic profiles, and Pulsatility Index (PI) of uterine artery in Doppler sonography in high risk mothers screening with Quadruple tests
Design
Study design:Random clinical trial of two blind sides (both patients and researchers) with parallel groups, Phase 2 in 60 patients.Randomization is done using Stat Trek software and based on random number methods.
Settings and conduct
Among high-risk pregnant women for preeclampsia, screened with Quadruple tests , 60 patients will be selected based on study criteria. Participants as well as researchers or evaluators are unaware of the allocation of study groups. Complementary and placebo capsules are similar in shape and size.This study will be performed at Beheshti Hospital in Kashan.
Participants/Inclusion and exclusion criteria
Entry conditions: Pregnant women at high risk for preeclampsia who have been screened with Quadruple tests , in the range of 18 to 40 years old and living in Kashan , with the first and single pregnancies and the absence of bone and chromosomal fetal abnormalities will enter the study after completing the consent form.
No entry conditions:Lack of willingness to cooperate at any stage of the project
Intervention groups
Intervention group: 200 micrograms of selenium capsules, 1 daily, orally for 12 weeks.
Control group: Selenium placebo capsules, 1 daily, orally for 12 weeks.
Main outcome variables
Highly sensitive C-reactive protein ( Hs-CRP ) (Initial consequence ) ؛ Systolic and diastolic blood pressure levels ؛ Nitric Oxide ؛ Glutathione ؛ Total antioxidants ؛ Malone De Aldeid ؛ Serum hemoglobin ؛ Serum Platelet ؛ Liver transaminases ؛ Serum Creatinine ؛ Serum Uric acid ؛ pulsatility Index of Uterine artery (PI ) ؛ Body Mass Index ( BMI ) ؛ Urinary protein excretion (Secondary consequence ) .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047701N1
Registration date:2020-06-26, 1399/04/06
Registration timing:prospective
Last update:2020-06-26, 1399/04/06
Update count:0
Registration date
2020-06-26, 1399/04/06
Registrant information
Name
Farah Shahin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0642
Email address
shahin-f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Selenium supplementation on clinical outcomes of Preeclampsia, metabolic profiles, and Pulsatility Index (PI ) of uterine artery in Doppler sonography in high risk mothers screening with Quadruple tests
Public title
The effect of Selenium supplementation in high risk mothers for Preeclampsia screened with Quadruple tests
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
High-risk pregnant women for pre-eclampsia screened with Quadruple tests
Age of 18 to 40
Pregnant woman living in Kashan
First pregnancy
Single pregnancy
Lack of bone and chromosomal abnormalities
Complete the consent form
Exclusion criteria:
Lack of willingness to cooperate at any stage of the project
Under age of 18 years old
Pregnant women who are currently smoking (Low risk for preeclampsia )
Pregnant women who are taking selenium supplements
Pregnant women who are taking thyroid medication
Pregnant women who are taking Aspirin , Heparin or Anti hypertensive drugs
Pregnant women who have chronic proteinuria
Abnormal scan anomalies
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using Stat Trek software and based on random number methods.In this method, the computer selects random numbers. Accounting is done by considering numbers for two groups.For example, even numbers will be in the intervention group and individual numbers will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and random allocation of researchers and participants in the study will remain hidden until the completion of statistical analysis.Another person in the clinic, who has no role in this clinical trial and is unaware of the random allocation, will assign the numbered bottles of the capsules to the study participants.Patients and researchers are unaware of the type of intervention, and after analyzing the data, the package codes are decrypted .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.008
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Highly sensitive C-reactive protein (Hs-CRP)
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Eliza Kit
Secondary outcomes
1
Description
Systolic and diastolic blood pressure levels
Timepoint
At the beginning of the study and then twice a week
Method of measurement
Mercury sphygmomanometer
2
Description
Nitric Oxide
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
3
Description
Glutathione
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
4
Description
Total antioxidants
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
5
Description
Malone De Aldeid
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Spectrophotometry
6
Description
pulsatility Index of Uterine artery
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Caller Doppler ultrasound
7
Description
Serum hemoglobin
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
laboratory kit
8
Description
Serum Platelet
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
laboratory kit
9
Description
Liver transaminases
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
laboratory kit
10
Description
Serum Creatinine
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
laboratory kit
11
Description
Serum Uric acid
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
laboratory kit
12
Description
Body Mass Index ( BMI )
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Weight by scales , Height by meter
13
Description
Urinary protein excretion
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Urine sample
Intervention groups
1
Description
Intervention group:200 micrograms of selenium capsules (Alpha Vitamins , Arian Sena , Tehran , Iran),1 daily, orally for 12 weeks . Intervention duration: 12 weeks .