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IRCT20150607022585N3 IRCT 2018-09-22 Bandare-abbas University of Medical Sciences Effect of vitamin D supplementation on fasting plasma glucose and insulin resistance indices in gestational diabetes mellitus Comparison of the effect of vitamin D supplementation on fasting plasma glucose and insulin resistance indices in pregnant women with gestational diabetes mellitus with a group of gestational diabetic pregnant women who do not receive vitamin D supplement 2015-11-04 anticipated 50 Complete https://irct.ir/trial/19459 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done using software and block randomization method. The participants were divided into two groups: intervention and control, Blinding description: Blinding was carried out at the participant level, researchers, expert in the field and analysing the data. 3 Gestational Diabetes Mellitus. Intervention 1: The control group received placebo twice (baseline and 21 days) in combination with calcium carbonate tablets 1000 milligram orally daily. Intervention 2: intervention group recieved 50,000 IU of oral vitamin D twice (baseline and 21 days) in combination with oral calcium carbonate 1000 milligram tablet daily. Yes - There is a plan to make this available What will be shared: The main Outcomes will be shared after deidentified participants When: Data will become available after publication of the whole results of the study for one year To whom: Data will be accessible for researcher in universities, research centers and academic institutions Conditions: The principal investigator of the trial, if other researchers need to more statistic analysis, after receiving the explicit request by electronic mail, will send the results of additional analysis to researchers through electronic mail. Where to obtain: To receive documents contact with principal investigator through electronic mail. The main researcher: Dr masoumeh Kheirandish, Endocrinologist, Endocrine and Metabolism Research Center, Hormozgan University of Medical Sciences 1) Electronic Mail: Kheirandishm@yahoo.com masoumeh.kheirandish@hums.ac.ir 2) After publication of study, the results, study protocol, and more documents will be accessible in http://eprints.hums.ac.ir How to obtain: After Receiving the request through electronic mail, the principal investigator will immediately response to applicant, and based on the type of requested document, the exact time of sending the documents will be explain. Comments:
public kimia Seddighi
Jomhori Blvd, shahid Mohammadi Hospital
Bandar-Abbas Iran (Islamic Republic of) 7919915519 +98 76 3222 0753 kimia.seddighi@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Masoumeh Kheirandish
Jomhouri Bvd. Shahid Mohammadi Hospital
Bandar-Abbas Iran (Islamic Republic of) 7919915519 +98 76 3335 4056 masoumeh.kheirandish@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Pregnant women diagnosed with gestational diabetes at the age of 18-40 years. Pregnant women diagnosed with gestational diabetes who had not a previous history of overt diabetes. Pregnant women diagnosed with gestational diabetes who do not receive vitamin D supplement. Pregnant women diagnosed with gestational diabetes who do not smoke or do not use any drugs Pregnant women with gestational diabetes who do not have any systemic diseases including liver disease, hypertension, hypothyroidism. Pregnant women diagnosed with gestational diabetes who do not have multiple pregnancies Pregnant women diagnosed with gestational diabetes who do not take any medication which affect glucose metabolism like steroids and insulin Pregnant women diagnosed with gestational diabetes who do not take and medication any glucose lowering drugs. 18 years 40 years Female unwillingness of participants to continue the study Start of insulin therapy during intervention miscarriage E10-E14 Diabetes Mellitus Placebo Treatment - Drugs The control group received placebo twice (baseline and 21 days) in combination with calcium carbonate tablets 1000 milligram orally daily intervention group recieved 50,000 IU of oral vitamin D twice (baseline and 21 days) in combination with oral calcium carbonate 1000 milligram tablet daily Fasting Plasma Glucose. Timepoint: at baseline of study- at the end of 6 weeks intervention. Method of measurement: commercial kit, enzymatic method. انسولین سرم. Timepoint: at baseline of study- at the end of 6 weeks intervention. Method of measurement: immunoassay (Elisa) kit. Insulin resistance index (HOMA-IR). Timepoint: at baseline of study- at the end of 6 weeks intervention. Method of measurement: using formula. Serum triglyceride. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit. Serum total cholesterol. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit. LDL-C. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit. HDL-C. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: enzymatic method by using commercial kit. Serum vitamin D concentration. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: Commercial kit. Serum calcium. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: Commercial kit. Serum phosphorus. Timepoint: at study baseline and at the end of 6 weeks intervention. Method of measurement: Commercial kit. Bandare-abbas University of Medical Sciences Approved 2015-07-20 Ethices Committee of Hormozgan University of Medical Sciences Chamran Blvd. Hormozgan University of Medical Sciences Bandar-Abbas Hormozgan Iran (Islamic Republic of)