Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID: NCT06567717
Run by: Cedars-Sinai Medical Center
People needed: 60
Starts: 2025-11-03
Expected to finish: 2027-01-01
Last updated by the study team: 2025-11-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 \&gt; 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
Extent of fibrotic changes must be greater than the extent of emphysema on HRCT
Able to take oral medication and willing to adhere to the study treatment regimen
Ability to utilize CS-Link, Zoom, or Doximity video conferencing for virtual study visits
Ability to complete PFT and 6 minute walk distance test every 12 weeks per standard of care under the order of a local treating pulmonologist
Ability to complete HRCT at baseline and 24 weeks per standard of care under the order of a local treating pulmonologist
Willingness to participate in home phlebotomy and to travel to a local Quest Diagnostics laboratory
Reside in one of the following states: California, Arizona, Georgia, Louisiana, Minnesota, Oregon

You may not qualify if…

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
Inability to obtain reproducible, high-quality pulmonary function tests
Likelihood of lung transplantation in the first 12 weeks of the study
Use of other IPF-directed therapies beside SOC including but not limited to endothelium receptor antagonists, interferon gamma-1b, N-acetylcysteine
Initiation of pirfenidone or nintedanib less than 60 days prior to screening
Current therapy or treatment within 60 days prior to screening of any cytotoxic or immunosuppressive medications, cytokine modulating therapies within 4 weeks of the screening visit
Chronic prednisone usage at a dose \&gt; 10 mg daily
Chronic use of any restricted medications known to have significant interactions with zinc supplementation (see Section 6.5)
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
History of active malignancy in the last 5 years, with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer
Prior allogeneic stem cell or solid organ transplantation
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications

Where it is running

Cedars-Sinai — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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