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

Primary Ciliary Dyskinesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489472
• Other study ID #: HSC-MS-19-0382
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Ricardo A Mosquera, MD
• Phone: (713) 500-5650
• Email: Ricardo.A.Mosquera[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Primary Ciliary Dyskinesia

Intervention

Dietary Supplement:
• Beet-it Juice
Patients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nasal NO as measured by a chemiluminescence analyzer		Baseline,after beet juice consumption(1 hour after consumption)
Primary	Change in nasal NO as measured by a chemiluminescence analyzer		Baseline,after beet juice consumption( 2 hours after consumption)
Primary	Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor		Baseline,after beet juice consumption(1 hour after consumption)
Primary	Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor		Baseline,after beet juice consumption(2 hours after consumption)
Secondary	Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)		after beet juice consumption(2 hours after consumption)
Secondary	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)