Primary Ciliary DyskinesiaNCT04489472
The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
A study testing Beet-it Juice in people with Primary Ciliary Dyskinesia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 99 years
- Conditions the study is for
- Primary Ciliary Dyskinesia
- What is being tested?
- Beet-it Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Experimental group:
- PCD patients
- Control Group:
- patients with no known chronic lung disease
- 18 years to 99 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Ricardo A Mosquera, MD, 713-500-5650, Ricardo.A.Mosquera@uth.tmc.edu
Diana Castillo, (713) 500-5359, Diana.J.MartinezCastillo@uth.tmc.edu
About this study
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
- Being tested
- Beet-it Juice
- Keywords
- Nitric oxide, Intranasal nitric oxide, Beet juice
- Medical subject headings
- Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet-it JuiceDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| PCD Group | Experimental | Not described Receives: Dietary Supplement: Beet-it Juice |
| Control Group | Placebo comparator | Not described Receives: Dietary Supplement: Beet-it Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal NO as measured by a chemiluminescence analyzer
Measured: Baseline,after beet juice consumption(1 hour after consumption)
Change in nasal NO as measured by a chemiluminescence analyzer
Measured: Baseline,after beet juice consumption( 2 hours after consumption)
Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
Measured: Baseline,after beet juice consumption(1 hour after consumption)
Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
Measured: 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)
Measured: 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
Measured: Baseline,after beet juice consumption(2 hours after consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start31 Jul 2019
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A. Mosquera, The University of Texas Health Science Center, Houston
- Investigators
- Ricardo A Mosquera, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489472
- Sponsor's protocol ID
- HSC-MS-19-0382
- Status last verified
- May 2023
- First submitted
- 2 Jul 2020
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
- ClinicalTrials.gov ID
- NCT04489472
- Acronym / sponsor ID
- HSC-MS-19-0382
- Conditions
- Primary Ciliary Dyskinesia
- Keywords
- Nitric oxide, Intranasal nitric oxide, Beet juice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCD Group | Experimental | Dietary Supplement: Beet-it Juice |
| Control Group | Placebo comparator | Dietary Supplement: Beet-it Juice |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- PCD patients
- patients with no known chronic lung disease
- 18 years to 99 years
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beet-it JuicePatients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate). | Dietary supplement | Control Group, PCD Group |
Primary outcome
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)
2 secondary outcomes
Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)
Time frame: after beet juice consumption(2 hours after consumption)
Change in lung function as measured by spirometry
Time frame: Baseline,after beet juice consumption(2 hours after consumption)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A Mosquera, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet-it Juice in people with Primary Ciliary Dyskinesia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A Mosquera, MD ((713) 500-5650, Ricardo.A.Mosquera@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nasal NO as measured by a chemiluminescence analyzer (time frame: Baseline,after beet juice consumption(1 hour after consumption)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.