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CTRI Number  CTRI/2017/02/007871 [Registered on: 15/02/2017] Trial Registered Retrospectively
Last Modified On: 21/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Vitamin D and chronic urticaria 
Scientific Title of Study   Effect of vitamin D on clinical outcome and biochemical profile in patients with vitamin D-deficient chronic urticaria- a randomized placebo controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana M 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Department of Biochemistry, Dhanvantri nagar, JIPMER, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9751799269  
Fax  04132272067  
Email  archujp15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Medha R 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Department of Biochemistry, JIPMER, Dhanvantri nagar, Gorimedu, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9486398875  
Fax  04132272067  
Email  linkmedha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Malathi M 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Dermatology, JIPMER, Dhanvantri nagar, Gorimedu, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7373842888  
Fax  04132272067  
Email  mmalathi.dr@live.com  
 
Source of Monetary or Material Support  
Intramural funds from Jawaharlal Institute of Postgraduate Medical Education & Research Dhanvantari Nagar Puducherry 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  Puducherry, 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Archana M  JIPMER  Department of Biochemistry, Second Floor, JIPMER Academic Centre, JIPMER, Dhanvantari Nagar, Puducherry-605006
Pondicherry
PONDICHERRY 		 9751799269
04132272067
archujp15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC(Human studies) JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Vitamin D deficient Chronic Urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Oral  Placebo once in 2 weeks for 3 months through oral route. 
Intervention  Tab Vitamin D Oral  60,000 IU once in 2 weeks for 3 months through oral route. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age and gender matched consenting patients with Chronic urticaria (presence of continuous or recurrent hives with or without angioedema for greater than 6 weeks duration) with vitamin D deficiency (serum vitamin D less than 20 ng per ml) attending the Dermatology Clinic in JIPMER during the study period 
 
ExclusionCriteria 
Details  Patients with
•Acute urticaria/physical urticaria/urticarial vasculitis
•Hereditary or acquired angioedema
•Symptoms of vitamin D deficiency such as musculoskeletal pain, fractures
•Patients with hepatic or renal dysfunction
•Malignancies/ Infections
•Inflammatory cutaneous disorders (psoriasis, lichen planus, pityriasis rubra pilaris, erythroderma, allergic contact dermatitis)
•Pregnant and lactating women will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Vitamin D on clinical outcome by USS(Urticaria Severity Score)  Baseline, 6 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the changes in levels of 25-hydroxy vitamin D, vitamin D binding protein, hs-CRP ,TGF-β, IL-17, IL-6.  Baseline and 12 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The purpose of this study is to asess the effect of vitamin D on clinical outcomes and on the changes in levels of 25-hydroxy vitamin D, vitamin D binding protein, hs-CRP ,TGF-β, IL-17, IL-6 and also to study its effect on medication use in Chronic Urticaria patients with vitamin D deficiency. We hypothesize that vitamin D deficient Chronic Urticaria patients receiving vitamin D would have a better clinical outcome and less disease severity when compared to those receiving placebo. Hence vitamin D would improve the quality of life of Chronic Urticaria patients.
 
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