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IRCT20161022030424N9 IRCT 2023-10-15 Tabriz University of Medical Sciences Docosahexaenoic acid and cobalamin in diabetic neuropathy Efficacy and safety of the daily oral supplementation of fish oil with high-dose docosahexaenoic acid content and cobalamin in patients with painful diabetic neuropathy 2023-11-22 anticipated 86 Complete https://irct.ir/trial/72962 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 86 people were divided into two groups in a simple random manner and after matching based on age with random block method using 2 blocks and random array subset selection (RASS) software 1) Doxahexaenoic acid oral supplement containing 1000 mg fish oil (500 mg docosahexaenoic acid and 150 mg of eicosapentaenoic acid) + oral vitamin B12 1000 micrograms 2) placebo are assigned, Blinding description: Active and placebo supplements will be prepared in exactly the same way in terms of shape, color and odor, and will be placed in a small envelope containing 28 capsules for each participant for 4-week consumption. The envelopes will be opened in the order in which the participants enter this stage from number 1, and an envelope containing the supplement will be provided to the participant for one month. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study. 3 Diabetic Neuropathy. Intervention 1: Intervention group: Doxahexaenoic acid oral supplement containing 1000 mg of fish oil (500 mg of docosahexaenoic acid and 150 mg of eicosapentaenoic acid) manufactured by Karen Pharmaceutical Company one tablet per day + oral vitamin B12 2500 micrograms manufactured by Hakim Pharmaceutical Company, one tablet per day for 12 week. Intervention 2: Control group: Doxahexanoic acid oral supplement placebo manufactured by Karen Pharmaceutical Company one tablet per day + oral vitamin B12 placebo manufactured by Hakim Pharmaceutical Company one tablet per day for 12 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 There is no further information.
public Seyed Kazem Shakouri
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 3692588521 +98 41 3336 1928 skshakouri@gmail.com Tabriz University of Medical Sciences scientific Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age of 45 and above Having diabetes based on WHO criteria (random plasma glucose ≥11·1 mmol/L, fasting plasma glucose ≥7·0 mmol/L, or 2-hour plasma glucose ≥11·1 mmol/L with oral glucose tolerance test) and based on the patient's record that has been in STABLE condition for at least three months (STABLE hypoglycemic drugs without insulin change +_20% and glycosylated hemoglobin [HbA1c] <9% at screening) Regular attendance at the hospital's outpatient clinic to ensure monitoring of blood sugar control and diabetes complications Documented clinical diagnosis of distal neuropathic pain based on pre-established criteria for peripheral neuropathy, neurological examination and EMG/NCV confirmed Experiencing neuropathic pain by scoring more than four in the Pain Diagnostic Questionnaire (DN4) or scoring more than 12 in the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S -LANSS) for at least three months 45 years no limit Both Clinical evidence of severe or acute cardiovascular disease (heart attack or stroke in the past year) Atrial fibrillation or other cardiac arrhythmias Renal disease Cerebrovascular disease and any other systemic disease Allergy to omega-3 supplements or fish G63.2 Polyneuropathy in diseases classified elsewhere Treatment - Drugs Placebo Intervention group: Doxahexaenoic acid oral supplement containing 1000 mg of fish oil (500 mg of docosahexaenoic acid and 150 mg of eicosapentaenoic acid) manufactured by Karen Pharmaceutical Company one tablet per day + oral vitamin B12 2500 micrograms manufactured by Hakim Pharmaceutical Company, one tablet per day for 12 week Control group: Doxahexanoic acid oral supplement placebo manufactured by Karen Pharmaceutical Company one tablet per day + oral vitamin B12 placebo manufactured by Hakim Pharmaceutical Company one tablet per day for 12 weeks Pain intensity. Timepoint: Pain intensity measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Visual Analogue Scale. Functional status. Timepoint: Functional status measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Sheehan Disability Scale. Serum nerve growth factor. Timepoint: Serum nerve growth factor measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. Serum uric Acid. Timepoint: Serum uric acid measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. Serum interleukin 6. Timepoint: Serum interleukin 6 measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. Serum interleukin 10. Timepoint: Serum interleukin 10 measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. Quality of life. Timepoint: Quality of life measurement at the beginning of the study (before the start of the intervention) and 12 weeks after the start of the intervention. Method of measurement: 36-item quality of life short form (sf-36). Tabriz University of Medical Sciences Approved 2023-09-04 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)