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Completed

NCT Number: NCT01578824

Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients

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.

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Key information

Conditions

Asthma Avitaminosis Bone Diseases Bone Diseases, Metabolic Bronchial Diseases Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Familial Hypophosphatemic Rickets Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Hypophosphatemia Hypophosphatemia, Familial Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Renal Tubular Transport, Inborn Errors Respiratory Hypersensitivity Respiratory Tract Diseases Rickets Rickets, Hypophosphatemic Urogenital Diseases Urologic Diseases Vitamin D Deficiency Vitamin D Resistant Rickets

Age range

3 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAMBAM Health Care Campus

Haifa, Israel, 31096

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Methacholine Challenge Test

Other

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

Other names: Airway Hyperresponsiveness test

Primary outcomes

  1. 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.

Secondary outcomes

  1. IgE

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

    in peripheral Blood count

  2. CBC

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

    in peripheral Blood count

  3. Fractional Exhaled NO

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

    determination of exhaled NO in Exhaled breath

  4. skin tests for inhaled allergens

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

  5. Inhaled breath condensate

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

  6. C reactive protein

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

    in peripheral Blood count

  7. 25 OH vitamin D3

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

    in peripheral Blood count

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2012
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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