AsthmaNCT01578824
Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
A study testing Methacholine Challenge Test in people with Asthma and Vitamin D Resistant Rickets, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets. Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study… Read more about this study
- Who is it for?
- Ages 3 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Vitamin D Resistant Rickets
- What is being tested?
- Methacholine Challenge Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Dec 2012
- 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 3 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Vitamin D Resistent Rickets
- Age between 3 - 40 years
Who cannot join
- Any Chronic Lung Disease
- Febrile Illness in last 2 weeks
- Inhaled Corticosteroids over the past 2 weeks
- Bronchodilators over the past 24 hours
- Participation in any other clinical studies over the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.
Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls.
Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
Read the detailed description
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.
Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D.
Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate.
Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls.
Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test.
Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits.
Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
- Conditions
- Asthma, Vitamin D Resistant Rickets
- Being tested
- Methacholine Challenge Test
- Keywords
- Rickets, Vitamin D, airway hyperreactivity, Exhaled breath condensate
- Medical subject headings
- Asthma, Familial Hypophosphatemic Rickets, Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine Challenge TestOther
Also called Airway Hyperresponsiveness test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Active comparator | Not described Receives: Other: Methacholine Challenge Test |
| Vitamin D resistant Rickets | Active comparator | Vitamin D resistant Rickets patients Receives: Other: Methacholine Challenge Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacholine Challenge Test
As assessed by methacholine challenge test with determination of PC20.
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
Secondary outcomes (7)
IgE
in peripheral Blood count
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
CBC
in peripheral Blood count
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
Fractional Exhaled NO
determination of exhaled NO in Exhaled breath
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
skin tests for inhaled allergens
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
Inhaled breath condensate
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
C reactive protein
in peripheral Blood count
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
25 OH vitamin D3
in peripheral Blood count
Measured: participants will be followed for the duration of hospital visit, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionDec 2012
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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Bentur, Prof., Principal investigator, Rambam MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578824
- Sponsor's protocol ID
- Vit D and asthma in VDRR CTIL
- Status last verified
- Jun 2013
- First submitted
- 9 Nov 2011
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
- ClinicalTrials.gov ID
- NCT01578824
- Acronym / sponsor ID
- Vit D and asthma in VDRR CTIL
- Conditions
- Asthma, Vitamin D Resistant Rickets
- Keywords
- Rickets, Vitamin D, airway hyperreactivity, Exhaled breath condensate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Apr 2012 (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.
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.
Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls.
Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
Detailed description
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.
Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D.
Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate.
Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls.
Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test.
Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits.
Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Active comparator | Other: Methacholine Challenge Test |
| Vitamin D resistant Rickets | Active comparator | Other: Methacholine Challenge TestVitamin D resistant Rickets patients |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Vitamin D Resistent Rickets
- Age between 3 - 40 years
Key exclusion criteria (5 listed)
- Any Chronic Lung Disease
- Febrile Illness in last 2 weeks
- Inhaled Corticosteroids over the past 2 weeks
- Bronchodilators over the past 24 hours
- Participation in any other clinical studies over the past 4 weeks
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 |
|---|---|---|
| Methacholine Challenge TestAlso: Airway Hyperresponsiveness testEvaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20 | Other | Healthy Control, Vitamin D resistant Rickets |
Primary outcome
Metacholine Challenge Test
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
As assessed by methacholine challenge test with determination of PC20.
7 secondary outcomes
IgE
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
CBC
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
Fractional Exhaled NO
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
skin tests for inhaled allergens
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
Inhaled breath condensate
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
C reactive protein
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
25 OH vitamin D3
Time frame: participants will be followed for the duration of hospital visit, an average of 3 hours
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 13 Jun 2013.
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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.
Lea Bentur, Prof. principal investigator
Rambam MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methacholine Challenge Test in people with Asthma and Vitamin D Resistant Rickets, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 5 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 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Metacholine Challenge Test (time frame: participants will be followed for the duration of hospital visit, an average of 3 hours). 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 13 Jun 2013.