High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

August 16, 2016 updated by: Keramatallah Jahanshahi, Shiraz University of Medical Sciences

High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D3 (Low dose)
Daily 600 unites of vitamin D + Cetirizine 10mg twice a day
Drug: Vitamin D3 (Low dose)
Daily 600 unites vitamin D
Other Names:
  • cholecalciferol
Experimental: Vitamin D3 (High dose)
Daily 4000 unites vitamin D + Cetirizine 10mg twice a day
Drug: Vitamin D3 (High dose)
Daily 4000 unites vitamin D
Other Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urticaria symptom severity questionnaire after 1 week
Time Frame: 1 weeks
Urticaria Symptom Severity ranging from 0 to 93
1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urticaria symptom severity questionnaire after 6 week
Time Frame: 6 weeks
Urticaria Symptom Severity ranging from 0 to 93
6 weeks
Urticaria symptom severity questionnaire after 12 week
Time Frame: 12 weeks
Urticaria Symptom Severity ranging from 0 to 93
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Principal Investigator: Keramatallah Jahanshahi, MD, shiraz University of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 93-01-01-8312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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