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

The University of Texas System (UT)

Status: Enrolling

Conditions: Primary Ciliary Dyskinesia

Treatments: Dietary Supplement: Beet-it Juice

Study type: Interventional

Funder types: Other

Identifiers

NCT04489472

HSC-MS-19-0382

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

PCD Group

Experimental group

Treatment:

Dietary Supplement: Beet-it Juice

Control Group

Placebo Comparator group

Treatment:

Dietary Supplement: Beet-it Juice