The effect of supplementation with alpha lipoic acid on serum levels of factors, disease enzymes, lipid fractions and oxidative stress in patients with psoriasis
Determining the effect of alpha lipoic acid supplementation on the serum levels of inflammatory factors, liver enzymes, lipid parameters and oxidative stress in patients with psoriasis
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized. The sample size was 17 people in each group, including attrition: 22 people in each group. The data were analyzed using SPSS ver. 19 will be subjected to statistical analysis. PASI standard (Psoriasis area and severity index) will be used to measure the progress or improvement of psoriasis disease.
Settings and conduct
This study will be a randomized controlled clinical trial that will be conducted on patients with psoriasis between February 1402 and June 1403 in Tehran. After being diagnosed by a specialist doctor from the Psoriasis Clinic of Razi Hospital, patients will be examined in terms of inclusion and exclusion criteria by examining the medical records and asking the patient directly.
Participants/Inclusion and exclusion criteria
1. Being 20 to 50 years old
2. Psoriasis diagnosis based on PASI criteria by a dermatologist
3. PASI number above 20 in psoriasis patients
Intervention groups
People in the intervention group will take a capsule containing 600 mg of alphalipoic acid, and people in the placebo group will take a capsule that is completely similar in appearance, color and smell to alphalipoic acid capsules daily for 2 months. The dose of alphalipoic acid used in this research and the duration of its use are based on previous studies
The effect of supplementation with alpha lipoic acid on serum levels of factors, disease enzymes, lipid fractions and oxidative stress in patients with psoriasis
Public title
The effect of supplementation with alpha lipoic acid on serum levels of factors, disease enzymes, lipid fractions and oxidative stress in patients with psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of psoriasis based on the PASI criteria by a dermatologist
PASI number above 20 in psoriasis patients
Exclusion criteria:
Any history of alcohol and tobacco use
Breastfeeding and pregnancy or pregnancy intention within the next 3 months
Use of biological drugs, corticosteroids, methotrexate, antibiotics
Having diabetes and the presence of any diagnosed neoplasia or malignancy
Use of antioxidants and omega-3 supplements in the last 3 months
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Study subjects will be blocked based on gender and BMI and then will be randomly divided into two intervention groups with alpha lipoic acid and placebo. Random assignment of people to the intervention or placebo group will be done by an experienced expert.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the subjects and researchers will be unaware of the existing grouping until the end of the study, and pills containing alpha lipoic acid and placebo will be given to subjects every 4 weeks by another person who has no knowledge of the research process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Keshavarz Boulevard-Qods Street
City
Tehran
Province
Tehran
Postal code
141556117
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.768
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L-40
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
ESR
Timepoint
At the beginning of the study (before the start of the intervention) and 8 weeks after the intervention
Method of measurement
Elisa
2
Description
ALT, AST, ALKP
Timepoint
At the beginning of the study (before the start of the intervention) and 8 weeks after the intervention
Method of measurement
Elisa
3
Description
TG, TC, HDL, LDL
Timepoint
At the beginning of the study (before the start of the intervention) and 8 weeks after the intervention
Method of measurement
Elisa
Secondary outcomes
1
Description
CRP
Timepoint
The beginning of the intervention (before the intervention) and after 8 weeks of the intervention
Method of measurement
Elisa
2
Description
MDA
Timepoint
The beginning of the intervention (before the intervention) and after 8 weeks of the intervention
Method of measurement
Elisa
Intervention groups
1
Description
Intervention group: The intervention group will receive 1 tablet of alphalipoic acid at a dose of 600 mg with water for 8 weeks. Alphalipoic acid tablets are purchased from Karen B. All patients will be monitored for pill consumption with a daily checklist and recall messages
Category
Treatment - Drugs
2
Description
Control group: The control group will receive 1 placebo tablet daily with water for 8 weeks. Placebo pills are purchased from Karen. All patients will be monitored for pill consumption with a daily checklist and recall messages
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi skin Hospital
Full name of responsible person
Sorayia ebrahim pour koujan
Street address
Vahdat eslami street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0220
Email
nutri.seam1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshad Khodarrahmanian
Street address
Vahdat eslami street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
nutri.seam1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
sorayia ebrahim pour koujan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Skin Specialist Hospital, Razi Dead End, Vahdat Islami Square, Vahdat Islami Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
nutri.seam1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sorayia ebrahim pour koujan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Skin Specialist Hospital, Razi Dead End, Vahdat Islami Square, Vahdat Islami Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
nutri.seam1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sorayia ebrahim pour koujan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Skin Specialist Hospital, Razi Dead End, Vahdat Islami Square, Vahdat Islami Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 8670 5503
Email
nutri.seam1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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