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

NCT01395589 | Completed Phase 1 DMC

• 1 other identifier: 1036
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Vitamin D Deficiency

Keywords

allergy; clinical trial; exacerbation; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  12 month

Secondary Outcomes (1)

• Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma

  12 month

Study Arms (2)

Injectable + oral vitamin D

ACTIVE COMPARATOR

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

Drug: Vitamin D

Oral-only Vitamin D

ACTIVE COMPARATOR

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

Drug: Vitamin D

Interventions

Vitamin D 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.

Injectable + oral vitamin D; Oral-only Vitamin D

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation, Pediatric Emergency Center,Alsaad.

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency; Hypersensitivity

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr.Khalid Al-Ansari

  Hamad Medical Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 15, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

QA (1)