The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of a dietary supplement rich in nitric oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat frequency assessed by high-speed digital video microscopy and on lung function assessed by spirometry in normal patients and patients with Primary ciliary dyskinesia (PCD).

Official Title
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The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.

Conditions
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Primary Ciliary Dyskinesia

Intervention / Treatment
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* Dietary Supplement: Beet-it Juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experimental group: PCD patients Control Group: patients with no known chronic lung disease 18 years to 99 years Exclusion Criteria(both PCD patients and control group): any other pulmonary co-morbidities and diseases entities like cystic fibrosis, nasal sinus surgery, nasal sinus hypoplasia/aplasia, deviated nasal septum, nasal polyps and with upper respiratory tract infection patients allergic to beet a known prolonged bleeding disorder.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCD Group<br> | Dietary Supplement: Beet-it Juice<br>* Patients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate).<br>|
| Placebo Comparator: Control Group<br> | Dietary Supplement: Beet-it Juice<br>* Patients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal NO as measured by a chemiluminescence analyzer |  | Baseline,after beet juice consumption(1 hour after consumption) | 
| Change in nasal NO as measured by a chemiluminescence analyzer |  | Baseline,after beet juice consumption( 2 hours after consumption) | 
| Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor |  | Baseline,after beet juice consumption(1 hour after consumption) | 
| Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor |  | Baseline,after beet juice consumption(2 hours after consumption) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM) |  | after beet juice consumption(2 hours after consumption) | 
| Change in lung function as measured by spirometry | spirometry is used to assess how well your lungs work by measuring how much air you inhale,how much you exhale and how quickly you exhale | Baseline,after beet juice consumption(2 hours after consumption) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric oxide, Intranasal nitric oxide, Beet juice