Trial of Vitamin D3 Supplementation in Paediatric Asthma
NCHVitDAst
Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma
1 other identifier
interventional
53
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Oct 2013
Shorter than P25 for not_applicable asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedDecember 3, 2015
December 1, 2015
7 months
October 10, 2014
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Paediatic Asthma Control Test (P-ACT)
15 weeks
Secondary Outcomes (6)
Global Initiative for Asthma Score
15 weeks
Pulmonary function
15 weeks
Height velocity
15 weeks
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
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTAL2,000iu vitamin D3 per day for 15 weeks
Placebo
PLACEBO COMPARATORAn identical placebo capsule daily for 15 weeks.
Interventions
Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.
Eligibility Criteria
You may qualify if:
- Previous clinical diagnosis of asthma
- Ability to perform pulmonary function tests
- Established on anti-asthmatic pharmacotherapy with no expected change
You may not qualify if:
- Use of medications that influence vitamin D metabolism or absorption
- Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Conor Kerleylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Basil Elnazir, MD
National Children's Hospital, Dublin 24, Ireland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD candidate
Study Record Dates
First Submitted
October 10, 2014
First Posted
April 28, 2015
Study Start
October 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
December 3, 2015
Record last verified: 2015-12