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

NCT ID: NCT01395589

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 597 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-06-30

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.

Conditions

Asthma; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Injectable + oral vitamin D

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

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

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.

Oral-only Vitamin D

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

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Khalid Ibrahim

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.Khalid Al-Ansari

Role: STUDY_CHAIR

Hamad Medical Corporation

Locations

Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.

Doha, , Qatar

Countries

Qatar

Other Identifiers

1036

Identifier Type: -

Identifier Source: org_study_id