Trial of Vitamin D3 Supplementation in Paediatric Asthma (NCHVitDAst)

Conor Kerley

Status: Completed

Conditions: Asthma

Treatments: Dietary Supplement: VItamin D3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02428322

NCH-ASTHMA-VIT.D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

2,000iu vitamin D3 per day for 15 weeks

Treatment:

Dietary Supplement: VItamin D3

Dietary Supplement: Placebo

Placebo

Placebo Comparator group

Description:

An identical placebo capsule daily for 15 weeks.

Treatment:

Dietary Supplement: Placebo