According to the previous studies, cost-benefit of vitamin E and also lack of serious side effects of vitamin E with dosage 400 IU per day, we decided to evaluate the intake of oral vitamin E in the treatment of atopic dermatitis and compare with placebo.
This study is a double blind clinical trial which seventy people with atopic dermatitis based on the Hanifin and Rajka’s diagnostic criteria randomly selected from educational skin clinics. These seventy people were divided randomly in two groups A and B with thirty five patients. The group A received drug package A and group B received drug package B. Since this study was double blinded, these packages, which contained vitamin E and placebo, were coded to A and B by corporator. Each group took the drug package four months. Extent, severity and subjective symptoms including itch and sleeplessness were measured by scored index every month. In addition every two weeks the patients were followed up by phone to make sure of using drug package and asking about any side effects or exacerbation of disease. Three months after finishing of intervention recurrence rate of atopic dermatitis were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105016350N1
Registration date:2011-05-31, 1390/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-31, 1390/03/10
Registrant information
Name
Arghavan Mokhtarian
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1626 1811
Email address
g_faghihi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of oral vitamin E on the treatment of atopic dermatitis and comparing with placebo
Public title
Effects of Vitamin E on the treatment of atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All people with atopic dermatitis based on the Hanifin and Rajka’s diagnostic criteria
in age range of 10-50 years except these:
1-Lactating woman, 2- Pregnant woman, 3- Severe form of a disease with scored index of more than 50, 4-Taking systemic corticosteroid or immunosuppressive drugs, 5- Coagulopathy, 6- Need to hospitalization, 7- History of allergy to vitamin E.
Exclushion criteria: 1- Getting pregnant during the treatment period, 2- Exacerbation of the disease, 3- Allergy symptoms to vitamin E.
Age
From 10 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chanceller for Research, School of Medicine, Isfahan university of medical sciences
Street address
Vice Chancellor of Research Office, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2009-07-26, 1388/05/04
Ethics committee reference number
388213
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Sleep
Timepoint
Monthly
Method of measurement
Visual analogue scale 0-10
2
Description
Itch
Timepoint
Monthly
Method of measurement
Visual analogue scale 0-10
3
Description
Extent of lesions
Timepoint
Monthly
Method of measurement
Transparent paper rating based on unit area
Secondary outcomes
1
Description
Gastrointestinal symptoms after taking vitamin E
Timepoint
monthly
Method of measurement
Questionnaire
2
Description
Skin rash or any new skin symptom
Timepoint
monthly
Method of measurement
Questionnaire
Intervention groups
1
Description
intervention group: vitamin E tablet 400 IU/ oral/ /daily/ I /for 4 months
Category
Treatment - Drugs
2
Description
control group: placebo tablet/ oral/daily/ I/ for 4 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin clinic of Nur hospital
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Skin clinic of Alzahra hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research
Full name of responsible person
Dr. Peyman Adibi
Street address
Vice Chancellor of Research Office, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
388213
Is the source of funding the same sponsor organization/entity?