Trial of Vitamin D3 Supplementation in Paediatric Asthma (NCHVitDAst)

December 1, 2015 updated by: Conor Kerley

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

53

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Paediatic Asthma Control Test (P-ACT)
Time Frame: 15 weeks
15 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conor Kerley

Investigators

  • Principal Investigator: Basil Elnazir, MD, National Children's Hospital, Dublin 24, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

April 22, 2015

First Posted (ESTIMATE)

April 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCH-ASTHMA-VIT.D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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