Protocol summary

Summary
Objective:To investigate the effect of Narrow Band UVB phototherapy on serum folate levels. Design:(Study group:patients with dermatological disorders including psoriasis,vitiligo or atopic dermatitis that are referred to phototherapy unit at Yahyanegad hospital; Sample size:30; No control group; Building:Not blinded; Randomization:Single arm study).Setting and conduct: 30 patients that are referred to phototherapy unit of the dermatology department at Yahyanegad hospital are enrolled in to the study. Serum folate levels are measured in all patients at the first visit before initiating of treatment and after thirty sessions of treatment. Serum folate levels are determined using Elisa method. Software SPSS are used to analyze the results. Inclusion criteria:patients with dermatological disorders including psoriasis,vitiligo or atopic dermatitis that undergoing NBUVB phototherapy; Exclusion criteria:Taking drugs that interface with folate metabolism; taking folate supplements; chronic diseases. Intervention: Narrow Band Ultera Violet B phototherapy; thirty session of treatment. Primary outcome variables:serum folate levels; Secondary outcome variables:UVB comulative doses

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015111525026N2
Registration date: 2015-12-21, 1394/09/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-21, 1394/09/30
Registrant information
Name
Azar Shirzadian kebria
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
a.shirzadiyan@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2015-10-25, 1394/08/03
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Narrow Band UVB phototherapy on serum folate level
Public title
The effect of phototherapy on serum folic acid level
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:patients diagnosed with dermatological disorders including psoriasis,vitiligo,atopic dermatitis that are referred to phototherapy unit of the dermatology department at Yahyanegad hospital; Exclusion criteria:taking drugs that interface with folate metabolism including methotrexate and anti epileptic; taking folate supplements; chronic diseases such as hepatic or renal diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Vice chancellor for research of Babol University of Medical Sciences,Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
Babol
Postal code
4717631367
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
MUBABOL.REC.1394.159

Health conditions studied

1

Description of health condition studied
Atopic dermatitis-vitiligo-psoriasis
ICD-10 code
L20-L80-L4
ICD-10 code description
Atopic dermatitis-vitiligo-psoriasis

Primary outcomes

1

Description
Serum folate levels
Timepoint
Baseline (before initiation of treatment)-after 30sessions of treatment
Method of measurement
Elisa

Secondary outcomes

1

Description
NB UVB total cumulative doses
Timepoint
Doses are recorded at each session
Method of measurement
J/cm2

Intervention groups

1

Description
Intervention group:Narrow Band UVB phototherapy; 30 sessions of treatments; No control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology department of Shahid Yahyanegad hospital
Full name of responsible person
Azar Shirzadian Kebria
Street address
Shahid Yahyanegad hospital,Mostafa Khomeini street,Modares street,Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Babol University of Medical Sciences
Full name of responsible person
Dr.Hadi Parsiyan
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azar Shirzadian kebria
Position
Assistant professor,Dermatologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
a.shirzadiyan@mubabol.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azar Shirzadian kebria
Position
Assistant professor,Dermatologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square,Babol
City
Babol
Postal code
4717631367
Phone
+98 11 3219 7667
Fax
Email
a.shirzadiyan@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azar Shirzadian kebria
Position
Assistant professor,Dermatologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences,Ganjafroose street,Karegar square, Babol
City
Babol
Postal code
4717631367
Phone
+98 11 3219 7667
Fax
Email
a.shirzadiyan@mubabol.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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