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NCT02873364 Clinical Trial

High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

Urticaria Clinical Trial

Official title:
High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02873364
Other study ID # 93-01-01-8312
Secondary ID
Status Recruiting
Phase Phase 3
First received August 11, 2016
Last updated August 16, 2016
Start date August 2016
Est. completion date January 2017

Study information
Verified date August 2016
Source Shiraz University of Medical Sciences
Contact Keramatallah Jahanshahi, MD
Phone +989177416523
Email kjahanshahi91@gmail.com
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D3 (High dose)
Daily 4000 unites vitamin D
• Vitamin D3 (Low dose)
Daily 600 unites vitamin D

Locations
Country Name City State
Iran, Islamic Republic of Shiraz University of Medical Sciences Shiraz Fars

Sponsors (1)
Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urticaria symptom severity questionnaire after 1 week Urticaria Symptom Severity ranging from 0 to 93 1 weeks No
Secondary Urticaria symptom severity questionnaire after 6 week Urticaria Symptom Severity ranging from 0 to 93 6 weeks No
Secondary Urticaria symptom severity questionnaire after 12 week Urticaria Symptom Severity ranging from 0 to 93 12 weeks No
See also
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Completed NCT00876369 - Vitamin D Levels in Subjects With Chronic Urticaria and Angioedema
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Completed NCT01371877 - The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment N/A
Completed NCT00751218 - A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735) Phase 4
Completed NCT03137069 - A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). Phase 2
Recruiting NCT05115136 - Using Doxepin for Urticaria Phase 3