Vitamin and Asthma Study | NCT01447173

Studies
Vitamin and Asthma Study

NCT01447173

Sponsor

Augusta University

Status

Completed

Last Update Posted

Oct 23, 2012Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Vitamin D

Countries

United States

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

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 3, 2011

First Submission Date that Met QC Criteria

Oct 4, 2011

First Posted Date

Oct 6, 2011Estimated

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

Oct 22, 2012

Last Update Posted Date

Oct 23, 2012Estimated

Description Module

Brief Summary

The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2000 IU vitamin D Daily	Experimental		Drug: Vitamin D
400 IU Vitamin D pill	Placebo Comparator		Drug: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug	Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill	2000 IU vitamin D Daily 400 IU Vitamin D pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Pulmonary Function Test (PFT) after vitamin D supplementation		4 weeks
Change in Asthma Control Test (ACT) scores after vitamin D supplementation		4-week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of asthma (under control)otherwise in good general health

Exclusion Criteria:

Poorly controlled asthma
Taking daily multivitamin or vitamin D supplementation
Taking oral steroid medication
History of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatrics Allergy Clinic at Georgia Health Sciences University		Augusta	Georgia	30912	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided