| CTRI Number |
CTRI/2022/07/044324 [Registered on: 26/07/2022] Trial Registered Prospectively |
| Last Modified On: |
30/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Adding vitamin D to the treatment of chronic urticaria can be helpful. |
|
Scientific Title of Study
|
Role of vitamin D supplementation on symptom score and quality of life in patients with chronic urticaria. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishtha Loona |
| Designation |
Junior Resident |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department OF Dermatology, Kalinga Institute of Medical Sciences(KIMS),KIIT Road, Bhubaneswar, Odisha 751024
Kalinga Institute of Medical Sciences(KIMS) Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
8283808184 |
| Fax |
|
| Email |
nishthaloona1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedarnath Dash |
| Designation |
Professor |
| Affiliation |
KIMS |
| Address |
Department OF Dermatology, Kalinga Institute of Medical Sciences(KIMS) Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024
Kalinga Institute of Medical Sciences(KIMS) Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
9890634707 |
| Fax |
|
| Email |
kedarnath.dash@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nishtha Loona |
| Designation |
Junior Resident |
| Affiliation |
KIMS |
| Address |
Department of dermatology, Kalinga Institute of Medical Sciences(KIMS) Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024
Kalinga Institute of Medical Sciences(KIMS) Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
8283808184 |
| Fax |
|
| Email |
nishthaloona1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences(KIMS),Bhubaneshwar |
|
|
Primary Sponsor
|
| Name |
KIMS |
| Address |
DEPT.OF DVL, Kalinga Institute of Medical Sciences(KIMS) Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishtha Loona |
Kalinga Institute of Medical Sciences |
Department of dermatology,venereology and leprosy
Khordha
ORISSA |
8283808184
nishthaloona1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L501||Idiopathic urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients receiving both antihistamines and vitamin d3 supplementation |
Patients Will receive Oral vitamin D3 60,000 IU weekly for 4 weeks,then one dose at the end of 8 weeks(total 5 doses) along with standard treatment of H1 non sedative antihistamine (tab.Levocetrizine ranging from 5 mg to 20 mg/day) depending on case to case and elemental calcium 500mg BD for 12 weeks |
| Comparator Agent |
Patients receiving only antihistamines |
Patients will receive only standard treatment of H1 non sedative antihistamine (tab.Levocetrizine ranging from 5 mg to 20 mg/day) and elemental calcium 500mg BD for 12weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age :20-60 years.
2. Sex : Both gender.
3. Chronic spontaneous urticaria patients having recurrent wheals occurring at least 3 times per week for more than 6 weeks within the past year.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA :
1. Acute urticaria patients.
2. Physical urticaria patients
3. Urticarial vasculitis patients.
4. Hereditory or acquired angioedema patients.
5. Those who have taken vitamin D supplements .
6. Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the reduction in urticaria activity score (UAS7) following the vitamin D supplementation along with standard treatment in comparison to only standard treatment in patients with chronic urticaria.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes include the effect of Vitamin D supplementation on the reduction in medication dosage and quality of life scores in CU. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A study to know the reduction in urticaria activity score
(UAS7) following the administration of vitamin D along with standard treatment
in comparison to only standard treatment at the end of 12 weeks and also the effect of
Vitamin D supplementation on the reduction in medication dosage and quality of
life scores in Chronic urticaria.Vitamin D is an immunoregulatory hormone and represents a relatively safe and
inexpensive supplement, with clinical evidence to support its consideration and
use as supplement for patients with CU. Given the above, there is an obvious
need for clinical studies to understand the clinical benefit of vitamin D. This
is of particular relevance because the Indian population is reported to have a
widespread prevalence of varying degrees (50–90%) of vitamin D deficiency. |