Trial of Vitamin D3 Supplementation in Paediatric Asthma

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT02428322
• Lead Sponsor: Conor Kerley

Brief Summary

Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (\<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.

Detailed Description

Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Previous clinical diagnosis of asthma
• Ability to perform pulmonary function tests
• Established on anti-asthmatic pharmacotherapy with no expected change

Exclusion Criteria

• Use of medications that influence vitamin D metabolism or absorption
• Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Paediatic Asthma Control Test (P-ACT)	15 weeks

Secondary Outcome Measures

Name	Time	Method
Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.	15 weeks
Mini paediatric asthma quality of life questionnaire	15 weeks
Global Initiative for Asthma Score	15 weeks
Height velocity	15 weeks	Rate of change in height
Pulmonary function	15 weeks	FEV1, FVC, FEV1:FVC
Asthma Diary	15 weeks	A 13 item diary to be filled out weekly by parents/gaurdians.