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

NCT04489472 | Unknown

• 1 other identifier: HSC-MS-19-0382
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Ciliary Dyskinesia

Keywords

Nitric oxide; Intranasal nitric oxide; Beet juice

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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)

Study Arms (2)

PCD Group

EXPERIMENTAL

Dietary Supplement: Beet-it Juice

Control Group

PLACEBO COMPARATOR

Dietary Supplement: Beet-it Juice

Interventions

Beet-it Juice DIETARY_SUPPLEMENT

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

Control Group; PCD Group

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Experimental group:
• PCD patients
• Control Group:
• patients with no known chronic lung disease
• years to 99 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Ricardo A Mosquera, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo A Mosquera, MD

CONTACT

(713) 500-5650; Ricardo.A.Mosquera@uth.tmc.edu

Diana Castillo

CONTACT

(713) 500-5359; Diana.J.MartinezCastillo@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 28, 2020
• Study Start: July 31, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)