Protocol summary
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Study aim
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ٍEvaluating the effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with diabetes
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Design
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This is a phase 3, triple blind randomized controlled clinical trial with a parallel design in which the target population is 50 eligible patients with peripheral diabetic neuropathy. Computer software (RAS: Random Allocation Software) will be used to randomize.
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Settings and conduct
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Sampling will be done in Nutrition Research Center. After the approval of the Ethics Committee and the registration of the trial in IRCT, the researcher will express the objectives of the study to the participants and obtain a form of informed consent. After completing the questionnaires, each person will be given 60 number of 500 mg identical capsules for bio-monthly use. monitoring will be blunt.Participants, researchers, analyst, and the safety and data monitoring committee will be blind
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women or men aged 40-70 years, type 2 diabetes based on the diagnosis of endocrinologist, peripheral diabetic neuropathy based on Michigan neuropathy screening tool.
Exclusion criteria: Peripheral neuropathy due to other diseases, other chronic diseases, pregnancy, breastfeeding.
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Intervention groups
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Participants will be allocated into one of two groups of organic selenium or placebo by an allocation ratio of 1: 1. They will take a daily 500 mg capsule containing 200 micrograms of selenium or placebo.
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Main outcome variables
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Symptoms of neuropathy; Severity of neuropathy; Serum levels of glycemic markers; Serum indicator of Pro-oxidant Antioxidant Balance (PAB)
General information
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Reason for update
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Under the above request and approval by the Center Council and Ethics Committee, the 4 study groups should be reduced to two groups: organic selenium and placebo, and the sample size should be reduced from 100 people in 4 groups to 50 people in 2 groups. Please agree.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131009014957N10
Registration date:
2020-08-03, 1399/05/13
Registration timing:
prospective
Last update:
2025-03-08, 1403/12/18
Update count:
1
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Registration date
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2020-08-03, 1399/05/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-09-22, 1399/07/01
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Expected recruitment end date
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2022-01-21, 1400/11/01
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Actual recruitment start date
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2021-04-21, 1400/02/01
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Actual recruitment end date
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2024-10-22, 1403/08/01
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Trial completion date
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2024-10-22, 1403/08/01
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Scientific title
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The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes: A parallel randomized controlled clinical trial
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Public title
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The effect of supplementation with organic selenium on peripheral neuropathy and biochemical markers in people with melitus diabetes.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-29, 1399/04/09
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Ethics committee reference number
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IR.TBZMED.REC.1399.322
Health conditions studied
1
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Description of health condition studied
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ِDiabetic peripheral neuropathy
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ICD-10 code
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G63*
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ICD-10 code description
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Polyneuropathy in diseases classified elsewhere
Primary outcomes
1
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Description
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Neuropathy symptoms
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Timepoint
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Baseline and 8 weeks after the intervention
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Method of measurement
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Michigan neuropathy screening tool
2
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Description
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Neuropathy severity
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Timepoint
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Baseline and 8 weeks after the intervention
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Method of measurement
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Toronto Clinical Scoring System
3
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Description
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Serum levels of glycemic markers (fasting blood sugar, insulin resistance, blood sugar monitored by the individual)
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Timepoint
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Baseline and 8 weeks after the intervention
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Method of measurement
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Biochemical methods and glucometer
4
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Description
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Pro-oxidant antioxidant balance
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Timepoint
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Pro-oxidant antioxidant balance
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Method of measurement
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Biochemical method
Secondary outcomes
1
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Description
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Quality of life score
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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World Health Organization quality of life assessment instrument (WHOQOL -BREF)
2
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Description
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Depression score
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Beck Depression Inventory-2
3
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Description
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Sleep quality score
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
4
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Description
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Sexual satisfaction score
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Larson's sexual satisfaction questionnaire (LSSQ)
5
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Description
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Side effects
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Questionnaire
6
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Description
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Satisfaction with medication
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Satisfaction rate questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Part of the outcome data will be published
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When the data will become available and for how long
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6 months after printing the results
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To whom data/document is available
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Researchers at institutions have access to data
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Under which criteria data/document could be used
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In order to help scientific progress in the field of research
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From where data/document is obtainable
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farshbafa@tbzmed.ac.ir
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What processes are involved for a request to access data/document
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Scientific approval of applicant by Tabriz University of Medical Sciences
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Comments
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