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Correction of Vitamin D in Asthma Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hamad Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Khalid Ibrahim, Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01395589
First received: June 29, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

Asthma is a major health problem affecting 22 million in the USA and 300 million people worldwide.

Recently vitamin D was identified as a possible co-factor and found that low vitamin D was associated with increased steroid use. In Qatar the prevalence of vitamin D deficiency among health care professionals was reported as high as 87% and 68.8% among school children.

In 1 year prospective study of patient with vitamin D and moderate -severe asthma will be followed after slow versus fast correction for asthma control.

This is randomized clinical trial study. INCLUSION CRITERIA: Children 2-14 years of age with moderate to severe asthma and proved to be Vitamin D deficient by serum level will be included in this study.

EXCLUSION CRITERIA: Prematurity (Gestational age 34 weeks or less),Patients on vitamin D therapy,Patients on seizure medication or diuretics,Patients on chronic steroid use for other reasons than asthma,Patient with chronic liver or kidney disease,Patients with inherited bone disease,Patients with hypo or hyper parathyroidism,patients with history of chronic lung disease other than asthma Methodology:- On arrival, patients with asthma with exacerbation will be assessed by the emergency staff. Children aged 2-14 years admitted to the inpatient/short stay unit for the treatment of moderate-severe asthma, meeting inclusion and exclusion criteria will be eligible for the study.

Guardians of eligible patients will be approached regarding the study, explaining the purpose and the treatment modalities. Patients will be included after obtaining a verbal consent.

All patients will be treated as usual. Blood sample for 25OH cholecalciferol level will be sent before discharge. Patients with vitamin D deficiency will be called to receive either daily oral vitamin D or single injection of intramuscular vitamin D and level of vitamin D will be repeated at 3,6,12 months. Followed up will continue for 1 year with a structured phone call interview by a research assistant at the first week of each month filling the survey for the previous month.

Ethical Considerations: Informed consent will be obtained from the guardian.

Sample Size:

a total of 105 patients will be recruited under this study. Statistical Analysis:- Univariate and multivariate analysis will be performed as required. Cox proportional hazards model will be used to compare the two treatment groups.


Condition Intervention Phase
Asthma
Drug: Vitamin D
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Correction of Vitamin D in Asthma Control in Vitamin D Deficient Children With Moderate-severe Asthma

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Acute asthma exacerbations avoidable events . [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Number of systemic steroid days for asthma treatment in the subsequent 12 months starting 7 days after the initiation of the intervention


Secondary Outcome Measures:
  • Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

    Number of days in the past month with limited activity due to asthma starting from 7 days after the initiation of the intervention .

    Number of school days missed in the past month due to asthma beginning 7 days after the initiation of the intervention .

    Number of days with sleeping difficulty in the past month due to asthma starting from 7 days after the initiation of the intervention .

    Frequency of use of beta-agonists for children with asthma starting from 7 days after the initiation of the intervention .



Estimated Enrollment: 105
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral vitamin D Drug: Vitamin D

patients with asthma with exacerbation will be admitted to the inpatient/short stay unit for the treatment of moderate-severe asthma .

Patients will be included after obtaining a verbal consent. Blood sample for 25OH cholecalciferol level will be sent before discharge. Patients with vitamin D deficiency will be called to receive either daily oral vitamin D or single injection of intramuscular vitamin D and level of vitamin D will be repeated at 3,6,12 months.

Active Comparator: intramuscular vitamin D Drug: Vitamin D

patients with asthma with exacerbation will be admitted to the inpatient/short stay unit for the treatment of moderate-severe asthma .

Patients will be included after obtaining a verbal consent. Blood sample for 25OH cholecalciferol level will be sent before discharge. Patients with vitamin D deficiency will be called to receive either daily oral vitamin D or single injection of intramuscular vitamin D and level of vitamin D will be repeated at 3,6,12 months.


Detailed Description:

Asthma is a major health problem affecting 22 million in the USA and 300 million people worldwide.

Many factors play a role in asthma control (e.g. genetic, obesity, sex, allergens, infections, smoke, and diet). Recently vitamin D was identified as a possible co-factor and found that low vitamin D was associated with increased steroid use.

In Qatar the prevalence of vitamin D deficiency among health care professionals was reported as high as 87% and 68.8% among school children.

In 1 year prospective study of patient with vitamin D and moderate -severe asthma will be followed after slow versus fast correction for asthma control.

This is randomized clinical trial study.

INCLUSION CRITERIA: Children 2-14 years of age with moderate to severe asthma and proved to be Vitamin D deficient by serum level will be included in this study.

EXCLUSION CRITERIA: Prematurity (Gestational age 34 weeks or less),Patients on vitamin D therapy,Patients on seizure medication or diuretics,Patients on chronic steroid use for other reasons than asthma,Patient with chronic liver or kidney disease,Patients with inherited bone disease,Patients with hypo or hyper parathyroidism,patients with history of chronic lung disease other than asthma Methodology:- On arrival, patients with asthma with exacerbation will be assessed by the emergency staff. Children aged 2-14 years admitted to the inpatient/short stay unit for the treatment of moderate-severe asthma, meeting inclusion and exclusion criteria will be eligible for the study.

Guardians of eligible patients will be approached regarding the study, explaining the purpose and the treatment modalities. Patients will be included after obtaining a verbal consent.

All patients will be treated as usual. Blood sample for 25OH cholecalciferol level will be sent before discharge. Patients with vitamin D deficiency will be called to receive either daily oral vitamin D or single injection of intramuscular vitamin D and level of vitamin D will be repeated at 3,6,12 months. Followed up will continue for 1 year with a structured phone call interview by a research assistant at the first week of each month filling the survey for the previous month.

Ethical Considerations: Informed consent will be obtained from the guardian.

Sample Size:

a total of 105 patients will be recruited under this study. Statistical Analysis:- Univariate and multivariate analysis will be performed as required. Cox proportional hazards model will be used to compare the two treatment groups.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 2-14 years of age with moderate to severe asthma and proved to be Vitamin D deficient by serum level will be included in this study.

EXCLUSION CRITERIA:

  • Prematurity (Gestational age 34 weeks or less)
  • Patients on vitamin D therapy
  • Patients on seizure medication or diuretics
  • Patients on chronic steroid use for other reasons than asthma
  • Patient with chronic liver or kidney disease
  • Patients with inherited bone disease
  • Patients with hypo or hyper parathyroidism
  • Patients with history of chronic lung disease other than asthma
  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: NCT01395589

Contacts
Contact: Dr.khalid alansari, FRCPC,FAAP 00974 4396006 kalanasri1@hmc.org.qa
Contact: Khalid ibrahim, MD 00974 55190403 kyiibrahim@hotmail.com

Locations
Qatar
Hamad Medical Corporation -Pediatric Emergency Center Enrolling by invitation
Doha, Qatar, 00974
Hamad Medical Corporation- Pediatriv Emergency Center Recruiting
Doha, Qatar, 00974
Sponsors and Collaborators
Hamad Medical Corporation
  More Information

No publications provided

Responsible Party: Khalid Ibrahim, Consultant, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01395589     History of Changes
Other Study ID Numbers: 1036
Study First Received: June 29, 2011
Last Updated: November 13, 2013
Health Authority: Qatar: Hamad Medical Corporation

Keywords provided by Hamad Medical Corporation:
vitamin D
emergency visits in patients with moderate to severe asthma after correction of vitamin D status.

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

ClinicalTrials.gov processed this record on November 23, 2014