High Dose Vitamin D Supplementation in Chronic Spontaneou... | NCT02873364

Studies
High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

NCT02873364

Sponsor

Shiraz University of Medical Sciences

Status

Unknown status

Last Update Posted

Aug 19, 2016Estimated

Enrollment

80Estimated

Phase

Phase 3

Conditions

Urticaria

Interventions

Vitamin D3 (High dose)
Vitamin D3 (Low dose)

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Aug 16, 2016

First Posted Date

Aug 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2016

Last Update Posted Date

Aug 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keramatallah Jahanshahi, Resident of internal medicine, Shiraz University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D3 (High dose)	Drug	Daily 4000 unites vitamin D	Vitamin D3 (High dose)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keramatallah Jahanshahi, MD	Contact	+989177416523		kjahanshahi91@gmail.com

Overall Officials

Name	Affiliation	Role
Keramatallah Jahanshahi, MD	Shiraz University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University of Medical Sciences	Recruiting	Shiraz	Fars		Iran

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014581	Urticaria

Ancestor Terms

ID	Term
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided