AsthmaNCHVitDAstNCT02428322
Trial of Vitamin D3 Supplementation in Paediatric Asthma
A study testing VItamin D3 in people with Asthma, run by Conor Kerley.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- VItamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previous clinical diagnosis of asthma
- Ability to perform pulmonary function tests
- Established on anti-asthmatic pharmacotherapy with no expected change
Who cannot join
- Use of medications that influence vitamin D metabolism or absorption
- Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Placebo, VItamin D3
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.
VItamin D3Dietary supplement
Soft gel capsules will contain 2,000IU vitamin D.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 2,000iu vitamin D3 per day for 15 weeks Receives: Dietary Supplement: Placebo; Dietary Supplement: VItamin D3 |
| Placebo | Placebo comparator | An identical placebo capsule daily for 15 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatic Asthma Control Test (P-ACT)
Measured: 15 weeks
Secondary outcomes (6)
Global Initiative for Asthma Score
Measured: 15 weeks
Pulmonary function
FEV1, FVC, FEV1:FVC
Measured: 15 weeks
Height velocity
Rate of change in height
Measured: 15 weeks
Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.
Measured: 15 weeks
Mini paediatric asthma quality of life questionnaire
Measured: 15 weeks
Asthma Diary
A 13 item diary to be filled out weekly by parents/gaurdians.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conor Kerley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Conor Kerley, University of Dublin, Trinity College
- Investigators
- Basil Elnazir, MD, Principal investigator, National Children's Hospital, Dublin 24, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428322
- Sponsor's protocol ID
- NCH-ASTHMA-VIT.D
- Acronym
- NCHVitDAst
- Status last verified
- Dec 2015
- First submitted
- 10 Oct 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma
- ClinicalTrials.gov ID
- NCT02428322
- Acronym / sponsor ID
- NCHVitDAst / NCH-ASTHMA-VIT.D
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Conor KerleyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Placebo, Dietary Supplement: VItamin D32,000iu vitamin D3 per day for 15 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAn identical placebo capsule daily for 15 weeks. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Previous clinical diagnosis of asthma
- Ability to perform pulmonary function tests
- Established on anti-asthmatic pharmacotherapy with no expected change
Key exclusion criteria (2 listed)
- Use of medications that influence vitamin D metabolism or absorption
- Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSoft gel capsules will be identical to the vitamin D intervention but contain no vitamin D. | Dietary supplement | Intervention, Placebo |
| VItamin D3Soft gel capsules will contain 2,000IU vitamin D. | Dietary supplement | Intervention |
Primary outcome
Paediatic Asthma Control Test (P-ACT)
Time frame: 15 weeks
6 secondary outcomes
Global Initiative for Asthma Score
Time frame: 15 weeks
Pulmonary function
Time frame: 15 weeks
Height velocity
Time frame: 15 weeks
Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.
Time frame: 15 weeks
Mini paediatric asthma quality of life questionnaire
Time frame: 15 weeks
Asthma Diary
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basil Elnazir, MD principal investigator
National Children's Hospital, Dublin 24, Ireland
Questions about this trial
What is this clinical trial studying?
A study testing VItamin D3 in people with Asthma, run by Conor Kerley.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paediatic Asthma Control Test (P-ACT) (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.