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IRCT20130616013678N29 IRCT 2019-03-26 Oroumia University of Medical Sciences Effect of vitamin D supplementation on control of gestational diabetes Study of the effect of vitamin D oral supplementation on glycemic control, serum levels of growth hormone, insulin-like growth factor-1 and lipid profile in gestational diabetes mellitus patients 2018-08-11 anticipated 30 Complete https://irct.ir/trial/37653 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Words of "intervention" and "control" will be writen on the 30 sheets and will be placed in Sealed envelope. Each patient will be asked to pick a envelope randomly, Blinding description: This study is a double blinded clinical trial that participants are randomly classified into two groups of intervention and control and none of them know in which group they are. Researchers are unaware which participants are receiving the real treatment. 3 Gestational Diabetes Mellitus. Intervention 1: Intervention group: The Intervention group will receive a Vitamin D3 2000 IU supplement daily for the period of 6 weeks. Intervention 2: Control group: The control group will receive a placebo that is similar to Vitamin D supplements but contains Paraffin oil daily for the period of 6 weeks. 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 -
public Dr Saeid Ghavamzadeh
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3278 0803 Ghavamzadeh_s@yahoo.com Oroumia University of Medical Sciences scientific Dr Saeid Ghavamz
Nutrition Department, Faculty of Medicine , Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3278 0803 Ghavamzadeh_s@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Detection of gestational diabetes between 24-28 weeks of pregnancy Tend to participate in the study Age category between 18-40 years old Consumption of daily multivitamins 18 years 40 years Female Twin or multiple pregnancy Having a body mass index greater than 40 Consumption of Vitamin D supplementation at least three months before the intervention Consumption of Insulin or Metformin People with cardiovascular diseases, digestive disorders, hypertension, inflammatory diseases and hypothyroidism Using cigarette and alcohol due to the effect on insulin metabolism and lipid profile O24 Diabetes Mellitus in pregnancy Treatment - Other Placebo Intervention group: The Intervention group will receive a Vitamin D3 2000 IU supplement daily for the period of 6 weeks. Control group: The control group will receive a placebo that is similar to Vitamin D supplements but contains Paraffin oil daily for the period of 6 weeks. 25 Hydroxy Vitamin D3. Timepoint: Before and 6 weeks after trials. Method of measurement: ElectroChemi Luminescence method. Fasting Blood Sugar. Timepoint: Before and 6 weeks after trials. Method of measurement: Enzymatic method. Serum Insulin. Timepoint: Before and 6 weeks after trials. Method of measurement: ELISA method. Total Cholesterol. Timepoint: Before and 6 weeks after trials. Method of measurement: Enzymatic method. Triglyceride. Timepoint: Before and 6 weeks after trials. Method of measurement: Enzymatic method. LDL Cholesterol. Timepoint: Before and 6 weeks after trials. Method of measurement: Enzymatic method. HDL Cholesterol. Timepoint: Before and 6 weeks after trials. Method of measurement: Enzymatic method. Growth Hormone. Timepoint: Before and 6 weeks after trials. Method of measurement: ELISA method. Insulin Like Growth Factor-1. Timepoint: Before and 6 weeks after trials. Method of measurement: ELISA method. Oroumia University of Medical Sciences Approved 2018-05-30 Ethics Committee of Urmia University of Medical Sciences Orjhans street, Resalat Blvd, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)