NCT01447173

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

October 3, 2011

Last Update Submit

October 22, 2012

Conditions

Keywords

AsthmaPulmonary Function TestVitamin D

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

2000 IU vitamin D Daily

EXPERIMENTAL
Drug: Vitamin D

400 IU Vitamin D pill

PLACEBO COMPARATOR
Drug: Vitamin D

Interventions

Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill

2000 IU vitamin D Daily400 IU Vitamin D pill

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatrics Allergy Clinic at Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 6, 2011

Study Start

December 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations