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Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations.

Primary Purpose

Asthma, Vitamin D Deficiency

Status
Completed
Phase
Phase 1
Locations
Qatar
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring allergy, clinical trial, exacerbation, pediatrics

Eligibility Criteria

2 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Injectable + oral vitamin D

Oral-only Vitamin D

Arm Description

Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.

Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.

Outcomes

Primary Outcome Measures

Acute asthma exacerbations avoidable events .
Rapid compared to maintenance oral supplementation with vitamin D significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months of treatment but not thereafter.

Secondary Outcome Measures

Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma
Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.

Full Information

First Posted
June 29, 2011
Last Updated
September 27, 2017
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01395589
Brief Title
Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations.
Official Title
Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The role of vitamin D in respiratory health remains uncertain. Whether vitamin D reduces clinically important exacerbations of childhood asthma remains uncertain. We compared rapid to maintenance vitamin D repletion analyzed by baseline vitamin D level.
Detailed Description
Recently published Cochrane metaanalysis suggested that vitamin D reduces the risk of severe asthma exacerbations, but only 22 children contributed to that analysis from a study that found no difference in acute care visits or rescue steroid administration. Altogether, randomized trials performed in children show promise solely in meta-analyses that use varied clinical outcomes and analysis approaches. Were vitamin D supplementation beneficial for children with asthma, it might prevent moderate to severe asthma exacerbations entirely in some children, reduce the overall frequency of exacerbations in a treated group, or both. To examine these possibilities, we designed a randomized explanatory study comparing rapid vs maintenance vitamin D supplementation for children with moderate-to-severe asthma and with low baseline vitamin D levels . Children presenting to the ED with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.The primary outcome was patient-initiated unplanned visits for asthma exacerbations,examined two ways: cumulative proportions with an exacerbation, and average exacerbation frequency. As this was a nutrient study, we analyzed treatment groups by quartile of baseline vitamin D level, collecting repeat levels and clinical observations at 3, 6, 9,and 12 months after enrollment. One hundred and sixteen patients in the IM+oral cohort vs 115 in the oral-only cohort had similar mean (SD) baseline levels: 15.1 (5.4) vs 15.8 (5.2) ng/mL (range, 3-25 ng/mL). There was no difference in the primary outcome over the entire 12-month observation period. However, rapid IM+oral supplementation significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months: the relative exacerbation rate for the IM+oral cohort compared with the oral-only cohort at 3 months was 0.48 (95% CI, 0.28-0.89; P ¼ .008); average exacerbation frequency per child analysis, relative rate 0.36 (95% CI, 0.13-0.87; P ¼ .017). So Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Vitamin D Deficiency
Keywords
allergy, clinical trial, exacerbation, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injectable + oral vitamin D
Arm Type
Active Comparator
Arm Description
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.
Arm Title
Oral-only Vitamin D
Arm Type
Active Comparator
Arm Description
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.
Primary Outcome Measure Information:
Title
Acute asthma exacerbations avoidable events .
Description
Rapid compared to maintenance oral supplementation with vitamin D significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months of treatment but not thereafter.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma
Description
Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children 2-14 years of age with moderate to severe asthma and proved to be Vitamin D deficient by serum level. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Khalid Al-Ansari
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
City
Doha
ZIP/Postal Code
3050
Country
Qatar

12. IPD Sharing Statement

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Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations.

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