Trial of Vitamin D3 Supplementation in Paediatric Asthma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02428322

Acronym

NCHVitDAst

Enrollment

Registered

2015-04-28

Start date

2013-10-31

Completion date

2014-05-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.

DIETARY_SUPPLEMENTVItamin D3

Soft gel capsules will contain 2,000IU vitamin D.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Paediatic Asthma Control Test (P-ACT)	15 weeks

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026