Recruiting

Dietary Supplement

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04489472

Conditions

Primary Ciliary Dyskinesia

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

Interventions

Beet-it Juice

Study Details

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

Study ID

NCT04489472

Start date

Jul 31, 2019

Status verified date

May, 2023

Completion date

May 1, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PCD Group

placebo comparator: Control Group

Interventions

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).

Primary outcome measure

  • Change in nasal NO as measured by a chemiluminescence analyzer [ Time Frame: Baseline,after beet juice consumption(1 hour after consumption) ]
  • Change in nasal NO as measured by a chemiluminescence analyzer [ Time Frame: Baseline,after beet juice consumption( 2 hours after consumption) ]
  • Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor [ Time Frame: Baseline,after beet juice consumption(1 hour after consumption) ]
  • Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor [ Time Frame: Baseline,after beet juice consumption(2 hours after consumption) ]

Central Contacts and Locations

Central contacts

Ricardo A Mosquera, MD

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

Diana Castillo

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Ricardo A Mosquera, MD

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

Diana Castillo

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 12, 2023

Last verified

May, 2023

Keywords

  • Nitric oxide
  • Intranasal nitric oxide
  • Beet juice

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2023-05-12.