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
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
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
NCT ID
NCT04489472
First Posted
July 2, 2020
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
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.
We'll reach out to this number within 24 hrs