Status:
NOT_YET_RECRUITING
Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
NIHR Southampton Respiratory Biomedical Research Centre
Asthma, Allergy and Inflammation Research (AAIR) Charity
Conditions:
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Eligibility:
All Genders
28-85 years
Phase:
NA
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research the investigators identified...
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is the prototypic chronic progressive fibrotic interstitial lung disease (ILD). Progressive disease is characterised by breathlessness and exercise limitation and t...
Eligibility Criteria
Inclusion
- Cases Inclusion Criteria
- Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on current established consensus guidelines.
- Medical Research Council (MRC) breathlessness grade 1-3
- Judged clinically stable for 3 months prior to recruitment by the investigator.
- Exclusion Criteria
- Baseline spirometry with FEV1/FVC ratio \< 0.7.
- Neoplastic disease undergoing treatment or active follow up.
- Presence of infection or exacerbation requiring hospitalization, within last 3 months.
- Current tobacco smoker or use of nicotine containing vapes (within 3months)
- Current use of ambulatory or long-term oxygen therapy (LTOT).
- Peripheral oxygen saturations \<85% during 6-minute walk-test.
- Any condition which would prevent completion of cycle-ergometer testing, pulmonary function testing (PFT) or 6-minute walk testing as judged by the investigator.
- Participation in a pulmonary rehabilitation (PR) program in the last 3 months.
- Any condition excluding CPET based on the absolute contraindication as the ACCP/ATS guidelines 2003
- Positive pregnancy test in females of childbearing age.
- Symptomatic peripheral vascular disease
- Controls Control Inclusion Criteria
- 1\) Age and sex-matched to participants in the IPF cohort Control Exclusion Criteria
- Inability to give informed written consent
- Malignancy (except localized squamous or basal cell skin carcinoma) undergoing active investigation, treatment, or follow-up
- Significant cardiorespiratory disease as judged by the investigator
- Diabetes mellitus requiring treatment with pharmacology therapy
- Current tobacco smoker or use of nicotine containing vapes (within 3months)
- Symptomatic peripheral vascular disease
Exclusion
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06488638
Start Date
September 1 2024
End Date
September 1 2026
Last Update
July 5 2024
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