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IRCT20121216011763N22 IRCT 2018-01-08 Vice chancellor for research, Isfahan University of Medical Sciences Effect of Folic Acid Supplementation among Diabetic Polyneuropathy Patients Effect of Folate Supplementations and their Relationship with Methyl Tetra Hydrofolate Reductase Folic Acid Polymorphisms on Metabolic, Inflammatory Indices and Nerve Conduction Velocity Variations in Patients with Diabetic Polyneuropathy 2016-03-19 anticipated 80 Complete https://irct.ir/trial/11957 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In present study, simple randomization method will be used. The randomization unit is individually and we will use the random number table method for random sequences. A random numbered table is a collection of numbers that are without a specific pattern, completely random and as table. The next step is allocation concealment and will use sequentially numbered, sealed, opaque envelopes. Then, based on the sample size, number of envelopes with aluminum surface are provided and each random sequence created on a card and the cards are inserted into the envelopes, respectively. At the time of registration for the participants, according to eligible participants, one of the envelopes is opened and the allocated group for participants is revealed, Blinding description: The present study is a triple blind method and participants, researcher, and statistical analyser will not know according to assigned intervention. 0 (exploratory trials) Diabetic Polyneuropathy. Intervention 1: Intervention group: Folic acid supplement, tablet 1 mg/day, 8- weeks, Maad pharmacy company. Intervention 2: Control group:placebo, 1 mg/day, 8- weeks, School of Pharmacy Isfahan university of medical sciences. Undecided - It is not yet known if there will be a plan to make this available
public Tayebeh Mottaghi
Hezarjarib StreetÙˆ Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3171 tmottaghi@yahoo.com Isfahan University of Medical Sciences scientific Dr Gholamreza Askari
Hezarjarib streetÙˆ Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) >20 Years Old Diabetic Neuropathy Approved by the Neurologist Desire to Consume Folic Acid during 8 Weeks 20 years 80 years Both Non-Diabetic Neuropathic Patients Pregnant Women Alcohol Users Smoking Multivitamin-minerals Containing Folic Acid, B12 and B6 Consumers during Study Drugs Consumers that may Interfere with the Absorption Folic Acid such as methotrexate, bacterium, antiepileptic and sulfa antibiotics E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy Treatment - Drugs Treatment - Drugs Intervention group: Folic acid supplement, tablet 1 mg/day, 8- weeks, Maad pharmacy company Control group:placebo, 1 mg/day, 8- weeks, School of Pharmacy Isfahan university of medical sciences. Nerve Conduction Velocity. Timepoint: week 0 and week 8. Method of measurement: EMG-NCV. Serum folic acid. Timepoint: week 0 and week 8. Method of measurement: Laboratory analysis (blood test). Serum vitamin B12. Timepoint: week 0 and week 8. Method of measurement: Laboratory analysis (blood test). Serum homocystein. Timepoint: week 0 and week 8. Method of measurement: Laboratory analysis (blood test). CRP. Timepoint: Week 0 and week 8. Method of measurement: Laboratory analysis (blood test). HbA1C. Timepoint: Week 0 and week 8. Method of measurement: Laboratory analysis (blood test). Vice chancellor for research, Isfahan University of Medical Sciences Approved 2017-03-10 Ethics committee of Isfahan university of Medical Sciences Hezar Jirib Street, Isfahan, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)