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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395589
First Posted: July 15, 2011
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Khalid Ibrahim, Hamad Medical Corporation
  Purpose
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.

Condition Intervention Phase
Asthma Vitamin D Deficiency Drug: Vitamin D Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations

Resource links provided by NLM:


Further study details as provided by Khalid Ibrahim, Hamad Medical Corporation:

Primary Outcome Measures:
  • Acute asthma exacerbations avoidable events . [ Time Frame: 12 month ]
    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 [ Time Frame: 12 month ]
    Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.


Enrollment: 597
Study Start Date: February 2011
Study Completion Date: June 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Injectable + oral vitamin D
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.
Drug: Vitamin D
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.
Active Comparator: Oral-only Vitamin D
Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL.
Drug: Vitamin D
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.

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.

  Eligibility

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395589


Locations
Qatar
Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Study Chair: Dr.Khalid Al-Ansari Hamad Medical Corporation
  More Information

Responsible Party: Khalid Ibrahim, Consultant, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01395589     History of Changes
Other Study ID Numbers: 1036
First Submitted: June 29, 2011
First Posted: July 15, 2011
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Khalid Ibrahim, Hamad Medical Corporation:
allergy
clinical trial
exacerbation
pediatrics

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