Trial of Vitamin D3 Supplementation in Paediatric Asthma

Asthma Clinical Trial

— NCHVitDAst  

Official title:

Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428322
• Other study ID #: NCH-ASTHMA-VIT.D
• Status: Completed
• Phase: N/A
• First received: October 10, 2014
• Last updated: December 1, 2015
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Health Service Executive
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Placebo
Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.
• VItamin D3
Soft gel capsules will contain 2,000IU vitamin D.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Conor Kerley

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paediatic Asthma Control Test (P-ACT)		15 weeks	No
Secondary	Global Initiative for Asthma Score		15 weeks	No
Secondary	Pulmonary function	FEV1, FVC, FEV1:FVC	15 weeks	No
Secondary	Height velocity	Rate of change in height	15 weeks	Yes
Secondary	Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.		15 weeks	Yes
Secondary	Mini paediatric asthma quality of life questionnaire		15 weeks	No
Secondary	Asthma Diary	A 13 item diary to be filled out weekly by parents/gaurdians.	15 weeks	No