Skip to main content
OpenTrials
Completed

NCT Number: NCT02428322

Trial of Vitamin D3 Supplementation in Paediatric Asthma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Vitamin D3

Dietary Supplement

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

Primary outcomes

  1. Paediatic Asthma Control Test (P-ACT)

    Time frame: 15 weeks

Secondary outcomes

  1. Global Initiative for Asthma Score

    Time frame: 15 weeks

  2. Pulmonary function

    Time frame: 15 weeks

    FEV1, FVC, FEV1:FVC

  3. Height velocity

    Time frame: 15 weeks

    Rate of change in height

  4. Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.

    Time frame: 15 weeks

  5. Mini paediatric asthma quality of life questionnaire

    Time frame: 15 weeks

  6. Asthma Diary

    Time frame: 15 weeks

    A 13 item diary to be filled out weekly by parents/gaurdians.

Sponsors and collaborators

Lead sponsor

Conor Kerley

Other

Registry information

Official study title

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

Acronym: NCHVitDAst

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.