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The effectiveness of vitamin D compared with placebo in vitiligo patients treated with Narrow Band UVB: A randomized control trial

Protocol summary

Summary
The purpose of this study is determination the effectiveness of vitamin D compared to placebo in vitiligo patients treated with Narrow Band UVB (NBUVB) in a PILOT, randomized, double-blind, single-center study. Inclusion criteria: patients with generalized Vitiligo or skin involvement more than or equal to five percent of the body surface. Exclusion criteria: patients with hemodialysis and renal failure, age less than 6 years, phototherapy sessions of less than 2 times a week. Randomization will be performed using the blocks of size 6, through block randomization method. After checking basic parameters like Ca, BUN, Cr, 25-OH VIT D, patients will be treated with placebo or vitamin D, 50000 units, orally, once every two weeks for two months. Ca, BUN, Cr and 25-OH VIT D will be measured again at 10th week after treatment. Patients will be visited monthly and photography will be done at the end of the second month. Interventions: Initially, all patients will be treated by NBUVB at the radiation dose of 0.3 J/CM2, twice a week. The dose will be increased by 20% per visit until skin burning or pain will occur. When symptomatic erythema will occur, phototherapy will be stopped until the lesions get healed. Phototherapy will be done twice a week up to 20 weeks. Patients will be followed up for 2 months for to evaluate relapse and treatment outcomes. Patients will be examined at the beginning and at the end of the treatment course and VASI (Vitiligo area severity index) will be calculated in order to assess the extent of their skin involvement.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2017031133014N1
Registration date: 2017-09-06, 1396/06/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Zahraalsadat Mousavi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 6080
Email address
mousavi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of vitamin D compared with placebo in vitiligo patients treated with Narrow Band UVB: A randomized control trial
Public title
The effect of vitamin D in vitiligo patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with generalized vitiligo or skin lesions equal or more than five percent of the body surface. Exclusion criteria: patients with hemodialysis and renal failure; receiving thiazide diuretics, lithium utilization; get systemic treatment in the last month; increasing serum leading to drug toxicity; age under 6 years old; phototherapy sessions less than 2 times a week.
Age
From 6 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be performed through block randomization method with the blocks of 6. In this method, the randomization will be done until the third person will be randomly assigned to a group, after which the individuals will be allocated to the other group automatically until the 6th blocks will be completed.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Shahre Daneshgahi, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2016-12-27, 1395/10/07
Ethics committee reference number
IR.AJUMS.REC.1395.756

Health conditions studied

1

Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo

Primary outcomes

1

Description
Changes in the extent of skin involvement
Timepoint
Every 2 months until 4 months
Method of measurement
Based on Vitiligo Area Scoring Index (VASI) Score. In this method body is divided into five separate regions: the hands, upper extremities, trunk,lower extremities and feet. The face and neck areas are assessed separately. One hand unit of the patient (the palm plus the volar surface of the digits) is used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. For each body region, VASI is determined as the product of the vitiligo area in hand units (set at 1% per unit) and the pattern of depigmentation within each hand-unit-measured patch (possible values of 10, 25,50, 75, 90 or 100%, which are illustrated with a descrip-tive atlas of patient photographs). VASI, applied to the whole body, will calculated using the following formula, (possible range 0–100): all body sites (hand units) × depigmentation.

Secondary outcomes

1

Description
Serum 25-hydroxyvitamin D level
Timepoint
At the beginning and at the 11th week of the study
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: Pearl VIT D 50000 unit, Orally, on pearl every 2 weeks, for 2 months Plus Narrow Band UVB, 0.3 J / CM2.
Category
Treatment - Drugs

2

Description
Control group: Placebo, Orally, Every 2 weeks a number for 2 months Plus Narrow Band UVB, 0.3 J / CM2.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin and Phototherapy Clinic, Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Dr Zahra ALsadat Mousavi
Street address
Skin Ward, Imam Khomeini Hospital, 24 Metry Street, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Shahre Daneshgahi, Ahvaz
City
Ahvaz
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, Ahvaz Jundishapur 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
Skin Ward, Ahvaz Imam Khomeini Hospital
Full name of responsible person
Dr Zahra ALsadat Mousavi
Position
Resident of Skin diseases
Other areas of specialty/work
Street address
Skin Ward, Imam Khomeini Hospital, 24 Metry Street, Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 21 2245 6080
Fax
+98 21 6345 3122
Email
nafmousavi@gmail.commousavi.z@ajums.ac.ir
Web page address
http://himam.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Ward, Ahvaz Imam Khomeini Hospital
Full name of responsible person
Dr Mohammad Omidian
Position
Associate Professor
Other areas of specialty/work
Street address
Skin Ward, Imam Khomeini Hospital, 24 Metry Street, Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 612222922
Fax
+98 612225763
Email
momidian@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Skin Ward, Ahvaz Imam Khomeini Hospital
Full name of responsible person
Dr Zahra ALsadat Mousavi
Position
Resident of Skin diseases
Other areas of specialty/work
Street address
Skin Ward, Imam Khomeini Hospital, 24 Metry Street, Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 21 2245 6080
Fax
+98 61 3222 5763
Email
nafmousavi@gmail.com
Web page address
http://himam.ajums.ac.ir

Sharing plan

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