Clinical trial of the effect of selenium supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction
Objective: The aim of this study is to determine the effects of selenium supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction. Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Pregnant women at risk for intrauterine growth restriction 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: 60 pregnant women at risk for intrauterine growth restriction of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Participants will be assigned to receive either selenium supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 14-wk intervention. Start and end date of intervention: 14 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601045623N64
Registration date:2016-01-31, 1394/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-01-31, 1394/11/11
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, Kashan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of selenium supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction
Public title
Effect of supplementation in treatment of pregnant women at risk for intrauterine growth restriction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women at risk for intrauterine growth restriction; aged 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:
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
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.Kaums.REC.1394.131
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
094
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 14 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 14 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 14 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 14 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
hs-CRP
Timepoint
At the beginning of the study and after 14 weeks of intervention
Method of measurement
Elisa kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 14 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Cholesterol
Timepoint
At the beginning of the study and after 14 weeks of intervention