Vitamin and Asthma Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01447173
First received: October 3, 2011
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Change in Pulmonary Function Test (PFT) after vitamin D supplementation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Asthma Control Test (ACT) scores after vitamin D supplementation [ Time Frame: 4-week ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2000 IU vitamin D Daily Drug: Vitamin D
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill
Placebo Comparator: 400 IU Vitamin D pill Drug: Vitamin D
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447173

Locations
United States, Georgia
Pediatrics Allergy Clinic at Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
  More Information

No publications provided

Responsible Party: Yanbin Dong, Professor, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01447173     History of Changes
Other Study ID Numbers: VDAS
Study First Received: October 3, 2011
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Asthma
Pulmonary Function Test
Vitamin D

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014