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IRCT20131009014957N10 IRCT 2020-08-03 Tabriz University of Medical Sciences The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes. The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes: A parallel randomized controlled clinical trial 2020-09-22 anticipated 50 Complete https://irct.ir/trial/49381 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants will be allocated into one of the two groups of organic selenium or placebo using computer software (RAS: Random Allocation Software) by four and 8 blocks with a 1:1 allocation ratio. Random allocation sequences will be generated by the non-involved person in the research. The flacons will be numbered from 1 to 50 based on the sequence produced, Blinding description: Each person will be given a 60-capsule mattee and enclosed flacons consisting of identical main medications or placebos for bi-monthly use that will be provided at the Nutrition Research Center. They will receive 500 mg capsules once a day containing 200 micrograms of selenium or placebo. All capsules will be identical, and all participants, researchers (who will also be evaluators of the outcomes), health care providers, and the Data Safety and Monitoring Committee will be blind. 3 ِDiabetic peripheral neuropathy. Intervention 1: Intervention group 1: Organic selenium group. They will take one 500 mg oral capsule containing 200 micrograms of selenium daily for 8 weeks. Organic selenium will be produced by the yeast Saccharomyces cerevisiae from sodium selenite. The rest of the capsule space will be filled with yeast powder. Organic selenium will be produced at the Nutrition Research Center. Intervention 2: Control group: Placebo group. They will take one 500 mg capsule containing starch daily for 8 weeks. The placebo capsules will be provided at the Nutrition Research Center. Yes - There is a plan to make this available What will be shared: Part of the outcome data will be published When: 6 months after printing the results To whom: Researchers at institutions have access to data Conditions: In order to help scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir How to obtain: Scientific approval of applicant by Tabriz University of Medical Sciences Comments:
public Azizeh Farshbaf-khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Majid Mobasseri
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 mobasserim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women or men aged 40-70 years Type 2 Diabetes based on the diagnosis of endocrinologist Diabetic peripheral neuropathy based on Michigan neuropathy screening tool 40 years 70 years Both Peripheral neuropathy due to other diseases (including alcohol consumption, chemotherapy, congenital disease, chronic inflammation, thyroid disorders, vitamin B12 deficiency, HIV, and idiopathic peripheral neuropathy) Other chronic diseases such as cancer, chronic renal failure, CVA, Parkinson, Alzheimer Increased risk of bleeding due to coagulation disorders Selenium or vitamin E supplementation during last 3 months Pregnancy Breastfeeding G63* Polyneuropathy in diseases classified elsewhere Treatment - Drugs Placebo Intervention group 1: Organic selenium group. They will take one 500 mg oral capsule containing 200 micrograms of selenium daily for 8 weeks. Organic selenium will be produced by the yeast Saccharomyces cerevisiae from sodium selenite. The rest of the capsule space will be filled with yeast powder. Organic selenium will be produced at the Nutrition Research Center. Control group: Placebo group. They will take one 500 mg capsule containing starch daily for 8 weeks. The placebo capsules will be provided at the Nutrition Research Center. Neuropathy symptoms. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Michigan neuropathy screening tool. Neuropathy severity. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Toronto Clinical Scoring System. Serum levels of glycemic markers (fasting blood sugar, insulin resistance, blood sugar monitored by the individual). Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Biochemical methods and glucometer. Pro-oxidant antioxidant balance. Timepoint: Pro-oxidant antioxidant balance. Method of measurement: Biochemical method. Quality of life score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: World Health Organization quality of life assessment instrument (WHOQOL -BREF). Depression score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory-2. Sleep quality score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Sexual satisfaction score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Larson's sexual satisfaction questionnaire (LSSQ). Side effects. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Questionnaire. Satisfaction with medication. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Satisfaction rate questionnaire. Tabriz University of Medical Sciences Approved 2020-06-29 Ethics committee of Tabriz University of Medical Sciences Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)