High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

NCT ID: NCT02873364

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D3 (Low dose)

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

Group Type ACTIVE_COMPARATOR

Vitamin D3 (Low dose)

Intervention Type DRUG

Daily 600 unites vitamin D

Vitamin D3 (High dose)

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

Group Type EXPERIMENTAL

Vitamin D3 (High dose)

Intervention Type DRUG

Daily 4000 unites vitamin D

Interventions

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Vitamin D3 (High dose)

Daily 4000 unites vitamin D

Intervention Type DRUG

Vitamin D3 (Low dose)

Daily 600 unites vitamin D

Intervention Type DRUG

Other Intervention Names

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cholecalciferol cholecalciferol

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Keramatallah Jahanshahi

Resident of internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keramatallah Jahanshahi, MD

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

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Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Keramatallah Jahanshahi, MD

Role: CONTACT

+989177416523

Facility Contacts

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Keramatallah Jahanshahi, MD

Role: primary

+989177416523

Other Identifiers

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93-01-01-8312

Identifier Type: -

Identifier Source: org_study_id

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