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IRCT2015010910891N2 IRCT 2015-08-19 Vice chancellor for research, Isfahan University of Medical Sciences Comparing the effect of high dose vitamin D3 intake on interleukin-10, 17 and quality of life in Multiple Sclerosis patients Comparing the effect of high dose vitamin D3 intake on interleukin-10, 17 and quality of life in Multiple Sclerosis patients 2013-12-22 anticipated 45 Complete https://irct.ir/trial/11304 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is performed by selection from sealed envelopes. N/A Multiple sclerosis. Intervention 1: Intervention group 1: 50,000IU vitamin D every five days, for 3 months vitamin D pearl Zahravi Pharmaceuticals. Intervention 2: Control group: placebo tablet, including inert substance one every five days, made by a Pharmacist.
public Fereshteh Ashtari
Kashani Hospital
Isfahan Iran (Islamic Republic of) +98 31 3235 0001 f_ashtari@med.mui.ac.ir Isfahan University of Medical Sciences scientific Fereshteh Ashtari
Kashani hospital
Isfahan Iran (Islamic Republic of) +32 350001 f_ashtari.med.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: a definite diagnosis of Relapsing-remitting Multiple Sclerosis (RRMS) according to Mc Donald criteria؛ age 18 to 55 years؛ EDSS (Expanded Disability Status Scale) score of less than 4؛ no relapse 30 days before inclusion؛ negative β-HCG test for women in child bearing age. Exclusion criteria: pregnancy؛ lactation؛ any other disease than Multiple Sclerosis؛ receiving>4000IU/d vitamin D؛ past history of renal or hepatic disease؛ relapse during the study؛ received corticosteroids in the previous 30 days؛ Calcium (Ca)>11mg/dl؛ Aspartate Transaminase(AST) or Alanine Transaminase(ALT)>3 times normal values؛ alkaline phosphatase (ALP)>2.5 times normal values. 18 years 55 years Both G35 Treatment - Drugs Placebo Intervention group 1: 50,000IU vitamin D every five days, for 3 months vitamin D pearl Zahravi Pharmaceuticals Control group: placebo tablet, including inert substance one every five days, made by a Pharmacist Interleukin 10, 17. Timepoint: At baseline and after 3 months. Method of measurement: Blood sample. Quality of life. Timepoint: 3 months. Method of measurement: MSQOL54. Vice chancellor for research, Isfahan University of Medical Sciences Approved 2013-12-20 ٍEthics committee of Isfahan University of Medical Sciences Hezar jerib Street, Azadi Square Isfahan Iran (Islamic Republic of)