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IRCT201601045623N64 IRCT 2016-01-31 Vice chancellor for research, Kashan University of Medical Sciences Effect of supplementation in treatment of pregnant women at risk for intrauterine growth restriction Clinical trial of the effect of selenium supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction 2015-12-23 anticipated 60 Complete https://irct.ir/trial/6094 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded. 3 Pregnancy. Intervention 1: Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5562 0608 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Pregnant women at risk for intrauterine growth restriction Aged 18 to 40 years 18 years 40 years Female Taking selenium supplements during past 3 months Hypo- and hyperthyroidism Urinary tract infection Pre-eclampsia Hypertension Diseases related to increased inflammation Smokers Kidney or liver diseases O94 Sequelae of complication of pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Drugs Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally. Total antioxidant. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry. Pulsatility index. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Sonography. Insulin. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry. Hs-CRP. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Elisa kit. Triglycerides. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit. Cholesterol. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit. Malondialdehyde. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry. HDL. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit. Vice chancellor for research, Kashan University of Medical Sciences Approved 2015-12-22 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)