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High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02873364
Recruitment Status : Unknown
Verified August 2016 by Keramatallah Jahanshahi, Shiraz University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Keramatallah Jahanshahi, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Urticaria Drug: Vitamin D3 (High dose) Drug: Vitamin D3 (Low dose) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria
Study Start Date : August 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives Vitamin D

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 Name: 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 Name: cholecalciferol




Primary Outcome Measures :
  1. Urticaria symptom severity questionnaire after 1 week [ Time Frame: 1 weeks ]
    Urticaria Symptom Severity ranging from 0 to 93


Secondary Outcome Measures :
  1. Urticaria symptom severity questionnaire after 6 week [ Time Frame: 6 weeks ]
    Urticaria Symptom Severity ranging from 0 to 93

  2. Urticaria symptom severity questionnaire after 12 week [ Time Frame: 12 weeks ]
    Urticaria Symptom Severity ranging from 0 to 93



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873364


Contacts
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Contact: Keramatallah Jahanshahi, MD +989177416523 kjahanshahi91@gmail.com

Locations
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Iran, Islamic Republic of
Shiraz University of Medical Sciences Recruiting
Shiraz, Fars, Iran, Islamic Republic of
Contact: Keramatallah Jahanshahi, MD    +989177416523    kjahanshahi91@gmail.com   
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Principal Investigator: Keramatallah Jahanshahi, MD Shiraz University of Medical Sciences

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Responsible Party: Keramatallah Jahanshahi, Resident of internal medicine, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02873364    
Other Study ID Numbers: 93-01-01-8312
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents