NCT01578824

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

November 9, 2011

Last Update Submit

June 12, 2013

Conditions

AsthmaVitamin D Resistant Rickets

Keywords

RicketsVitamin Dairway hyperreactivityExhaled breath condensate

Outcome Measures

Primary Outcomes (1)

  • Metacholine Challenge Test

    As assessed by methacholine challenge test with determination of PC20.

    participants will be followed for the duration of hospital visit, an average of 3 hours

Secondary Outcomes (7)

  • IgE

    participants will be followed for the duration of hospital visit, an average of 3 hours

  • CBC

    participants will be followed for the duration of hospital visit, an average of 3 hours

  • Fractional Exhaled NO

    participants will be followed for the duration of hospital visit, an average of 3 hours

  • skin tests for inhaled allergens

    participants will be followed for the duration of hospital visit, an average of 3 hours

  • Inhaled breath condensate

    participants will be followed for the duration of hospital visit, an average of 3 hours

  • +2 more secondary outcomes

Study Arms (2)

Healthy Control

ACTIVE COMPARATOR
Other: Methacholine Challenge Test

Vitamin D resistant Rickets

ACTIVE COMPARATOR

Vitamin D resistant Rickets patients

Other: Methacholine Challenge Test

Interventions

Methacholine Challenge TestOTHER

Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20

Also known as: Airway Hyperresponsiveness test
Healthy ControlVitamin D resistant Rickets

Eligibility Criteria

Age3 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Vitamin D Resistent Rickets
  • Age between 3 - 40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM Health Care Campus

Haifa, Israel, 31096, Israel

Location

MeSH Terms

Conditions

AsthmaFamilial Hypophosphatemic RicketsRickets

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRickets, HypophosphatemicBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesHypophosphatemia, FamilialRenal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersHypophosphatemiaPhosphorus Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Lea Bentur, Prof.

    Rambam MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

April 17, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

IL(1)