Feasibility of a Decentralized Trial of Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis

What is the Purpose of this Study?

The purpose of this study is to determine whether it is possible to conduct a clinical trial comparing the supplements zinc and nicotinamide riboside with placebo (inactive substance), in addition to standard treatment, for people with idiopathic pulmonary fibrosis (IPF) who are over 50 years old. The study is designed to allow participants to complete procedures at home and with their treating pulmonologists, a model that is referred to as “decentralized.” The goal is to determine whether a decentralized trial can provide researchers with the same type of answers as a conventional clinical trial while being less burdensome to participants. The study also aims to learn whether zinc and nicotinamide riboside can improve physical functioning or other aspects of quality of life in people with IPF. While both these supplements are considered safe by the U.S. Food and Drug Administration (FDA) and are available commercially for purchase without a prescription, they are not approved by the FDA to treat IPF. Researchers will assess whether taking zinc and nicotinamide riboside along with usual treatments for IPF can help improve lung function, physical abilities, or overall quality of life. This study is limited to patients who reside in the following six states: California, Arizona, Georgia, Louisiana, Minnesota, Oregon. Patients must be willing and able to use secure video conferencing programs (such as Zoom) to participate in the study.

Eligibility

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Be under active treatment for IPF by a local pulmonologist
4. Age \> 50 years

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Be under active treatment for IPF by a local pulmonologist
4. Age \> 50 years
5. Confident diagnosis of IPF per the latest ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF10
1. 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
2. Subjects must have HRCT pattern of definite or probable UIP
3. 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
4. Extent of fibrotic changes must be greater than the extent of emphysema on HRCT
6. Able to take oral medication and willing to adhere to the study treatment regimen
7. Ability to utilize CS-Link, Zoom, or Doximity video conferencing for virtual study visits
8. 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
9. Ability to complete HRCT at baseline and 24 weeks per standard of care under the order of a local treating pulmonologist
10. Willingness to participate in home phlebotomy and to travel to a local Quest Diagnostics laboratory
11. Reside in one of the following states: California, Arizona, Georgia, Louisiana, Minnesota, Oregon

Exclusion Criteria:

1. 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
2. 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)
3. Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
4. Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or the first study visit
5. Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
6. Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
7. Any condition that in the opinion of the investigators would confound the ability to interpret data from the study
8. Any comorbid condition that is likely to result in death within the next year
9. Inability to obtain reproducible, high-quality pulmonary function tests
10. Likelihood of lung transplantation in the first 12 weeks of the study
11. Use of other IPF-directed therapies beside SOC including but not limited to endothelium receptor antagonists, interferon gamma-1b, N-acetylcysteine
12. Initiation of pirfenidone or nintedanib less than 60 days prior to screening
13. 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
14. Chronic prednisone usage at a dose \> 10 mg daily
15. Chronic use of any restricted medications known to have significant interactions with zinc supplementation (see Section 6.5)
16. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
17. 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
18. 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
19. 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
20. Prior allogeneic stem cell or solid organ transplantation
21. 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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Feasibility of a Decentralized Double-Blind Randomized Controlled Trial of Zinc and Nicotinamide Riboside for the Treatment of Idiopathic Pulmonary Fibrosis

Study Details

Disease Type/Condition

Other

Principal Investigator

Zaman, Tanzira

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003680

ClinicalTrials.gov ID

NCT06567717

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org