Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis (NCT06567717) | Clinical Trial Compass
RecruitingPhase 2
Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
United States60 participantsStarted 2025-11-03
Plain-language summary
The goal of this clinical trial is to learn if a clinical trial for idiopathic pulmonary fibrosis (IPF) can recruit and retain participants from their home to study whether a combination of zinc and nicotinamide riboside can treat iIPF. The main questions are:
Can the investigators recruit participants, and can participants complete study procedures without physically coming into specific clinical trial sites? Can people with IPF experience improvement in symptoms, quality of life, or functioning if they are take these supplements? The investigators will compare zinc and nicotinamide riboside to matched placebos (look-alike substances that contain no drug) to see if these supplements treat symptoms or lung function in people with IPF.
Participants will:
Take drug these supplements twice a day for 24 weeks. Complete pulmonary function testing and six minute walk tests with their own pulmonologists every 12 weeks. Complete a high resolution CT scan at the start and end of the study. Complete video study visits with the research team every 4 weeks. Complete surveys about their symptoms and the number of times they take the medication.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Be under active treatment for IPF by a local pulmonologist
✓. Age \> 50 years
✓. Confident diagnosis of IPF per the latest ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF10
✓. Subjects must have a high-resolution computed tomography (HRCT) completed in the 6 months as part of their standard of care prior to informed consent
✓. Subjects must have HRCT pattern of definite or probable UIP
✓. Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy as part of their standard of care showing histopathology consistent with UIP
Exclusion criteria
✕. FVC \< 40% of predicted, DLCO \< 30% of predicted, FEV1/FVC with Z-score \< -1.645 or confidence interval \<1.0 within 3 months of screening. If Z-scores or confidence intervals are not available, then FEV1/FVC \< the lower limit of normal will be used as exclusion
✕. Evidence of secondary etiologies of ILD (signs/symptoms of connective tissue disease, including ANA titer \> 1:80, history of exposures related to hypersensitivity pneumonitis, history of drug related pulmonary toxicity, occupational exposures)
✕. Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
✕. Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or the first study visit
✕. Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
✕. Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
✕. Any condition that in the opinion of the investigators would confound the ability to interpret data from the study
✕. Any comorbid condition that is likely to result in death within the next year