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

Not Applicable

Recruiting

• Conditions: Primary Ciliary Dyskinesia
• Interventions: Dietary Supplement: Beet-it Juice

• Registration Number: NCT04489472
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-31
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCD Group	Beet-it Juice	-
Control Group	Beet-it Juice	-

Primary Outcome Measures

Name	Time	Method
Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor	Baseline,after beet juice consumption(2 hours after consumption)
Change in nasal NO as measured by a chemiluminescence analyzer	Baseline,after beet juice consumption( 2 hours after consumption)

Secondary Outcome Measures

Name	Time	Method
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	Baseline,after beet juice consumption(2 hours after consumption)	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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States