NCT02873364

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

August 11, 2016

Last Update Submit

August 16, 2016

Conditions

Urticaria

Outcome Measures

Primary Outcomes (1)

  • Urticaria symptom severity questionnaire after 1 week

    Urticaria Symptom Severity ranging from 0 to 93

    1 weeks

Secondary Outcomes (2)

  • Urticaria symptom severity questionnaire after 6 week

    6 weeks

  • Urticaria symptom severity questionnaire after 12 week

    12 weeks

Study Arms (2)

Vitamin D3 (Low dose)

ACTIVE COMPARATOR

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

Drug: Vitamin D3 (Low dose)

Vitamin D3 (High dose)

EXPERIMENTAL

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

Drug: Vitamin D3 (High dose)

Interventions

Vitamin D3 (High dose)DRUG

Daily 4000 unites vitamin D

Also known as: cholecalciferol
Vitamin D3 (High dose)
Vitamin D3 (Low dose)DRUG

Daily 600 unites vitamin D

Also known as: cholecalciferol
Vitamin D3 (Low dose)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

RECRUITING

MeSH Terms

Conditions

Urticaria

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Keramatallah Jahanshahi, MD

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keramatallah Jahanshahi, MD

CONTACT

+989177416523kjahanshahi91@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of internal medicine

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 19, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IR(1)