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High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

Primary Purpose

Urticaria

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D3 (High dose)
Vitamin D3 (Low dose)
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks

Exclusion Criteria:

  • Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation

Sites / Locations

  • Shiraz University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vitamin D3 (Low dose)

Vitamin D3 (High dose)

Arm Description

Daily 600 unites of vitamin D + Cetirizine 10mg twice a day

Daily 4000 unites vitamin D + Cetirizine 10mg twice a day

Outcomes

Primary Outcome Measures

Urticaria symptom severity questionnaire after 1 week
Urticaria Symptom Severity ranging from 0 to 93

Secondary Outcome Measures

Urticaria symptom severity questionnaire after 6 week
Urticaria Symptom Severity ranging from 0 to 93
Urticaria symptom severity questionnaire after 12 week
Urticaria Symptom Severity ranging from 0 to 93

Full Information

First Posted
August 11, 2016
Last Updated
August 16, 2016
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02873364
Brief Title
High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria
Official Title
High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 (Low dose)
Arm Type
Active Comparator
Arm Description
Daily 600 unites of vitamin D + Cetirizine 10mg twice a day
Arm Title
Vitamin D3 (High dose)
Arm Type
Experimental
Arm Description
Daily 4000 unites vitamin D + Cetirizine 10mg twice a day
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 (High dose)
Other Intervention Name(s)
cholecalciferol
Intervention Description
Daily 4000 unites vitamin D
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 (Low dose)
Other Intervention Name(s)
cholecalciferol
Intervention Description
Daily 600 unites vitamin D
Primary Outcome Measure Information:
Title
Urticaria symptom severity questionnaire after 1 week
Description
Urticaria Symptom Severity ranging from 0 to 93
Time Frame
1 weeks
Secondary Outcome Measure Information:
Title
Urticaria symptom severity questionnaire after 6 week
Description
Urticaria Symptom Severity ranging from 0 to 93
Time Frame
6 weeks
Title
Urticaria symptom severity questionnaire after 12 week
Description
Urticaria Symptom Severity ranging from 0 to 93
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks Exclusion Criteria: Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keramatallah Jahanshahi, MD
Phone
+989177416523
Email
kjahanshahi91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keramatallah Jahanshahi, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keramatallah Jahanshahi, MD
Phone
+989177416523
Email
kjahanshahi91@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

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