The effect of supplementation with organic selenium, vitamin E, and organic selenium-vitamin E on peripheral neuropathy and biochemichal markers in people with melitus diabetes: factorial randomized controlled clinical trial.
ٍEvaluating the effect of supplementation with organic selenium, vitamin E, and combination of organic selenium-vitamin E on peripheral neuropathy and biochemical markers in people with diabetes
Design
This is a phase 3, triple blind randomized controlled clinical trial with a factorial design in which the target population is 100 eligible patients with peripheral diabetic neuropathy. Computer software (RAS: Random Allocation Software) will be used to randomize.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Participants will be allocated into one of four groups of organic selenium, vitamin E, combination of organic selenium and vitamin E, or placebo by an allocation ratio of 1: 1: 1: 1. They will take a daily 500 mg capsule containing 400 IU of vitamin E, or 200 micrograms of selenium, or 400 IU of vitamin E-200 micrograms of selenium, or placebo.
Main outcome variables
Symptoms of neuropathy; Severity of neuropathy; Serum levels of glycemic markers; Serum indicator of Pro-oxidant Antioxidant Balance (PAB)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131009014957N10
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2020-08-03, 1399/05/13
Update count:1
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation with organic selenium, vitamin E, and organic selenium-vitamin E on peripheral neuropathy and biochemichal markers in people with melitus diabetes: factorial randomized controlled clinical trial.
Public title
The effect of supplementation with organic selenium, vitamin E, and organic selenium-vitamin E on peripheral neuropathy and biochemichal markers in people with melitus diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into one of the four groups of organic selenium, vitamin E, combination of organic selenium-vitamin E, or Placebo using computer software (RAS: Random Allocation Software) by four and 8 blocks with a 1: 1: 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 100 based on the sequence produced.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Each person will be given a 60-capsule, mattee, and enclosed flacons consisted of identical main medications or placebos for bi-monthly use that will be provided at the Nutrition Research Center. They will receive 500 mg capsule once a day containing 400 IU vitamin E , or 200 micrograms selenium, or 400 IU vitamin E along with 200 micrograms 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.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.TBZMED.REC.1399.322
Health conditions studied
1
Description of health condition studied
ِDiabetic peripheral neuropathy
ICD-10 code
G63*
ICD-10 code description
Polyneuropathy in diseases classified elsewhere
Primary outcomes
1
Description
Neuropathy symptoms
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Michigan neuropathy screening tool
2
Description
Neuropathy severity
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Toronto Clinical Scoring System
3
Description
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
4
Description
Pro-oxidant antioxidant balance
Timepoint
Pro-oxidant antioxidant balance
Method of measurement
Biochemical method
Secondary outcomes
1
Description
DHEA serum levels
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using Elisa method
2
Description
Quality of life score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
World Health Organization quality of life assessment instrument (WHOQOL -BREF)
3
Description
Depression score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Beck Depression Inventory-2
4
Description
Sleep quality score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
5
Description
Sexual satisfaction score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Larson's sexual satisfaction questionnaire (LSSQ)
6
Description
Side effects
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Questionnaire
7
Description
Satisfaction with medication
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Satisfaction rate questionnaire
Intervention groups
1
Description
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 at the Nutrition Research Center.
Category
Treatment - Drugs
2
Description
Intervention group 2: Vitamin E group. They will take one 500 mg capsule daily containing 400 IU of vitamin E (alpha-tocopherol) for 8 weeks. Vitamin E capsules will be provided at the Nutrition Research Center.
Category
Treatment - Drugs
3
Description
Intervention group 3: Organic selenium and Vitamin E combined group (Interaction group) .They will take one 500 mg capsule containing 400 IU of vitamin E (alpha-tocopherol) - 200 micrograms of selenium will be consumed for 8 weeks. Vitamin E- Organic Selenium capsules will be provided at the Nutrition Research Center. In this group, concurrent and interaction effects of two independent variables will be evaluated on dependent variables. .
Category
Treatment - Drugs
4
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Research Center
Full name of responsible person
Azizeh Farshbaf-Khalili
Street address
Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Fax
+98 41 3335 2295
Email
farshbafa@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Central building of Tabriz University of Medical Sciences., Azadi St., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
farshbafa@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mobasseri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
mobasserim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-khalili
Position
Assistant Profeassor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
farshbafa@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the outcome data will be published
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers at institutions have access to data
Under which criteria data/document could be used
In order to help scientific progress in the field of research
From where data/document is obtainable
farshbafa@tbzmed.ac.ir
What processes are involved for a request to access data/document
Scientific approval of applicant by Tabriz University of Medical Sciences