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

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).

Study Overview

• Status: Recruiting
• Conditions: Primary Ciliary Dyskinesia
• Intervention / Treatment: Dietary supplement: Beet-it Juice

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo A Mosquera, MD; Phone Number: (713) 500-5650; Email: Ricardo.A.Mosquera@uth.tmc.edu
• Study Contact Backup: Name: Diana Castillo; Phone Number: (713) 500-5359; Email: Diana.J.MartinezCastillo@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Diana Castillo; Phone Number: (713) 500-5359; Email: Diana.J.MartinezCastillo@uth.tmc.edu
      • Contact: Ricardo A Mosquera, MD; Phone Number: 713-500-5650; Email: Ricardo.A.Mosquera@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	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).
Experimental: PCD Group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Ricardo A Mosquera, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Nitric oxide; Intranasal nitric oxide; Beet juice
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Movement Disorders; Abnormalities, Multiple; Ciliopathies; Dyskinesias; Ciliary Motility Disorders
• Other Study ID Numbers: HSC-MS-19-0382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No