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IRCT20170513033941N26 IRCT 2018-01-07 National Institute for Medical Research Development of Iran (NIMAD) Effect of combined vitamin E and zinc supplementation in treatment of gestational diabetes mellitus Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus 2017-11-27 anticipated 60 Complete https://irct.ir/trial/28012 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, after balanced blocked randomisation, all participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. 3 Gestational diabetes mellitus. Intervention 1: Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 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) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients with gestational diabetes mellitus. Individuals aged 18 to 40 years. 18 years 40 years Female Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention Insulin therapy required during the intervention Pre-eclampsia Eclampsia Hypo and hyperthyroidism O24.9 Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium Treatment - Drugs Placebo Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally. Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation using HOMA formula. Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Expressed levels of PPAR-γ gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. LDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. VLDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit. Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: PCR. National Institute for Medical Research Development of Iran (NIMAD) Approved 2017-11-26 Ethics committee of National Institute for Medical Research Development of Iran (NIMAD) National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)