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Trial of Vitamin D3 Supplementation in Paediatric Asthma

NCT ID: NCT02428322

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

2,000iu vitamin D3 per day for 15 weeks

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

VItamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

An identical placebo capsule daily for 15 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

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

Intervention Type DIETARY_SUPPLEMENT

VItamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conor Kerley

OTHER

Sponsor Role lead

Responsible Party

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Conor Kerley

PhD candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Basil Elnazir, MD

Role: PRINCIPAL_INVESTIGATOR

National Children's Hospital, Dublin 24, Ireland

Other Identifiers

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NCH-ASTHMA-VIT.D

Identifier Type: -

Identifier Source: org_study_id