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

Primary Purpose

Primary Ciliary Dyskinesia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beet-it Juice
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ciliary Dyskinesia focused on measuring Nitric oxide, Intranasal nitric oxide, Beet juice

Eligibility Criteria

4 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PCD Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Change in nasal NO as measured by a chemiluminescence analyzer
Change in nasal NO as measured by a chemiluminescence analyzer
Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor

Secondary Outcome Measures

Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)
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

Full Information

First Posted
July 2, 2020
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04489472
Brief Title
The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
Official Title
The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ciliary Dyskinesia
Keywords
Nitric oxide, Intranasal nitric oxide, Beet juice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCD Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Beet-it Juice
Intervention Description
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 Information:
Title
Change in nasal NO as measured by a chemiluminescence analyzer
Time Frame
Baseline,after beet juice consumption(1 hour after consumption)
Title
Change in nasal NO as measured by a chemiluminescence analyzer
Time Frame
Baseline,after beet juice consumption( 2 hours after consumption)
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)
Time Frame
after beet juice consumption(2 hours after consumption)
Title
Change in lung function as measured by spirometry
Description
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
Time Frame
Baseline,after beet juice consumption(2 hours after consumption)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo A Mosquera, MD
Phone
(713) 500-5650
Email
Ricardo.A.Mosquera@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Castillo
Phone
(713) 500-5359
Email
Diana.J.MartinezCastillo@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A Mosquera, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo A Mosquera, MD
Phone
713-500-5650
Email
Ricardo.A.Mosquera@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Diana Castillo
Phone
(713) 500-5359
Email
Diana.J.MartinezCastillo@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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