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Study aim
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Determining the efficacy and safety of oral high-dose docosahexaenoic acid fish oil and cobalamin supplementation in patients with diabetic neuropathy accompanied by pain
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Design
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Clinical trial with a control group, with parallel groups, triple blind, randomized, phase 3 on 86 patients. Random Allocation Software (RAS) was used for randomization.
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Settings and conduct
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Patients attending outpatient clinics at the Emam Reza Hospital of Tabriz University of Medical Sciences who have been diagnosed with diabetic neuropathy will be invited to an initial assessment to determine if they meet the inclusion and exclusion criteria. Then the patients will be randomly assigned to receive either the doxahexanoic acid and vitamin B12 or the placebo for 12 weeks.
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Participants/Inclusion and exclusion criteria
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Entry conditions: age 45 years and older, suffering from diabetes according to WHO criteria, regular attendance at the hospital's outpatient clinic, documented clinical diagnosis of distal neuropathic pain, experience of neuropathic pain based on the neuropathic pain diagnosis questionnaire
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Conditions of non-entry: clinical evidence of cardiovascular disease (cardiac arrhythmias, stroke, etc.), Renal disease, cerebrovascular disease, allergy to omega-3 supplements or fish
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Intervention groups
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Intervention group 1: Doxahexaenoic acid oral supplement containing 1000 mg of fish oil (500 mg of docosahexaenoic acid and 150 mg of eicosapentaenoic acid) + oral vitamin B12 2500 micrograms for 12 weeks
Intervention group 2: Doxahexanoic acid oral supplement placebo + vitamin B12 placebo for 12 weeks
Active and placebo supplements will be prepared in exactly the same way in terms of shape, color and odor.
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Main outcome variables
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Pain intensity, functional status, and serum levels of nerve growth factor, uric acid, interleukin 6 and 10