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Trial of Vitamin D3 Supplementation in Paediatric Asthma (NCHVitDAst)

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ClinicalTrials.gov Identifier: NCT02428322
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Conor Kerley, University of Dublin, Trinity College

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.

Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: Placebo Dietary Supplement: VItamin D3 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma
Study Start Date : October 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D

Arm Intervention/treatment
Experimental: Intervention
2,000iu vitamin D3 per day for 15 weeks
Dietary Supplement: Placebo
Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.

Dietary Supplement: VItamin D3
Soft gel capsules will contain 2,000IU vitamin D.

Placebo Comparator: Placebo
An identical placebo capsule daily for 15 weeks.
Dietary Supplement: Placebo
Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.




Primary Outcome Measures :
  1. Paediatic Asthma Control Test (P-ACT) [ Time Frame: 15 weeks ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428322


Sponsors and Collaborators
Conor Kerley
Investigators
Principal Investigator: Basil Elnazir, MD National Children's Hospital, Dublin 24, Ireland

Responsible Party: Conor Kerley, PhD candidate, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT02428322     History of Changes
Other Study ID Numbers: NCH-ASTHMA-VIT.D
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents