Idiopathic Pulmonary FibrosisPhase 2NCT06567717
Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Zinc and Nicotinamide riboside in people with Idiopathic Pulmonary Fibrosis, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Zinc and Nicotinamide riboside
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai
Los Angeles, California, 90048
Tanzira Zaman, MD, 424-314-0585, GroupLungResearch@cshs.org
About this study
Official title: Feasibility of a Decentralized Double-Blind Randomized Controlled Trial of Zinc and Nicotinamide Riboside for the Treatment of Idiopathic Pulmonary Fibrosis
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.
Read more
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.
Read the detailed description
This trial aims to determine the feasibility of conducting a decentralized randomized controlled trial of zinc and nicotinamide riboside versus matched placebos in addition to standard of care therapy for idiopathic pulmonary fibrosis. The investigators hypothesize that it will be feasible to remotely recruit 60 participants over 52 weeks and retain them in such a trial over 24 weeks of treatment. The investigators also hypothesize that participants will be able to complete study procedures at their local clinical facilities per standard of care without coordination by local study personnel.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Zinc, Placebos for zinc and nicotinamide riboside, Nicotinamide riboside
- Keywords
- ipf, pulmonary fibrosis, idiopathic pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonias, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDrug
Zinc has not previously been investigated in the treatment of IPF.
Placebos for zinc and nicotinamide ribosideOther
These will be identical in appearance to the active substances
Nicotinamide ribosideDrug
Nicotinamide riboside has not previously been investigated in the treatment of IPF.
| Study group | Role | What they receive |
|---|---|---|
| Combination Supplements | Experimental | Zinc and nicotinamide riboside Receives: Drug: Zinc; Drug: Nicotinamide riboside |
| Placebo | Placebo comparator | Placebo-controls for both zinc and nicotinamide riboside Receives: Other: Placebos for zinc and nicotinamide riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Retention
Feasibility is defined as 80% or more of the enrolled patients complete the 24-week treatment Additional feasibility assessments include the recruitment rate over 52 weeks and the retention rate
Measured: From study activation to 78 weeks
Secondary outcomes (1)
Recruitment Rate
Number of participants who are recruited over 52 weeks divided by 60, expressed as a percent
Measured: From study activation to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start3 Nov 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanzira Zaman, Cedars-Sinai Medical Center
- Investigators
- Tanzira Zaman, MD, Principal investigator, Cedars-Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567717
- Sponsor's protocol ID
- Zn-NR-001
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Our study group would like to perform and publish additional analyses from the results of this trial.
Publications
Shi B, Wang W, Korman B, Kai L, Wang Q, Wei J, Bale S, Marangoni RG, Bhattacharyya S, Miller S, Xu D, Akbarpour M, Cheresh P, Proccissi D, Gursel D, Espindola-Netto JM, Chini CCS, de Oliveira GC, Gudjonsson JE, Chini EN, Varga J. Targeting CD38-dependent NAD+ metabolism to mitigate multiple organ fibrosis. iScience. 2020 Dec 7;24(1):101902. doi: 10.1016/j.isci.2020.101902. eCollection 2021 Jan 22.
PubMed 33385109Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stodkilde-Jorgensen H, Moller N, Brenner C, Treebak JT, Jessen N. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018 Aug 1;108(2):343-353. doi: 10.1093/ajcn/nqy132.
PubMed 29992272Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.
PubMed 31278280Covarrubias AJ, Perrone R, Grozio A, Verdin E. NAD+ metabolism and its roles in cellular processes during ageing. Nat Rev Mol Cell Biol. 2021 Feb;22(2):119-141. doi: 10.1038/s41580-020-00313-x. Epub 2020 Dec 22.
PubMed 33353981
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Decentralized Double-Blind Randomized Controlled Trial of Zinc and Nicotinamide Riboside for the Treatment of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06567717
- Acronym / sponsor ID
- Zn-NR-001
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- ipf, pulmonary fibrosis, idiopathic pulmonary fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial aims to determine the feasibility of conducting a decentralized randomized controlled trial of zinc and nicotinamide riboside versus matched placebos in addition to standard of care therapy for idiopathic pulmonary fibrosis. The investigators hypothesize that it will be feasible to remotely recruit 60 participants over 52 weeks and retain them in such a trial over 24 weeks of treatment. The investigators also hypothesize that participants will be able to complete study procedures at their local clinical facilities per standard of care without coordination by local study personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Supplements | Experimental | Drug: Zinc, Drug: Nicotinamide ribosideZinc and nicotinamide riboside |
| Placebo | Placebo comparator | Other: Placebos for zinc and nicotinamide ribosidePlacebo-controls for both zinc and nicotinamide riboside |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincZinc has not previously been investigated in the treatment of IPF. | Drug | Combination Supplements |
| Placebos for zinc and nicotinamide ribosideThese will be identical in appearance to the active substances | Other | Placebo |
| Nicotinamide ribosideNicotinamide riboside has not previously been investigated in the treatment of IPF. | Drug | Combination Supplements |
Primary outcome
Feasibility of Retention
Time frame: From study activation to 78 weeks
Feasibility is defined as 80% or more of the enrolled patients complete the 24-week treatment Additional feasibility assessments include the recruitment rate over 52 weeks and the retention rate
1 secondary outcome
Recruitment Rate
Time frame: From study activation to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Background: PubMed 33385109Shi B, Wang W, Korman B, Kai L, Wang Q, Wei J, Bale S, Marangoni RG, Bhattacharyya S, Miller S, Xu D, Akbarpour M, Cheresh P, Proccissi D, Gursel D, Espindola-Netto JM, Chini CCS, de Oliveira GC, Gudjonsson JE, Chini EN, Varga J. Targeting CD38-dependent NAD+ metabolism to mitigate multiple organ fibrosis. iScience. 2020 Dec 7;24(1):101902. doi: 10.1016/j.isci.2020.101902. eCollection 2021 Jan 22.
- Background: PubMed 29992272Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stodkilde-Jorgensen H, Moller N, Brenner C, Treebak JT, Jessen N. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018 Aug 1;108(2):343-353. doi: 10.1093/ajcn/nqy132.
- Background: PubMed 31278280Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.
- Background: PubMed 33353981Covarrubias AJ, Perrone R, Grozio A, Verdin E. NAD+ metabolism and its roles in cellular processes during ageing. Nat Rev Mol Cell Biol. 2021 Feb;22(2):119-141. doi: 10.1038/s41580-020-00313-x. Epub 2020 Dec 22.
- Individual participant dataSharing planned: No. Our study group would like to perform and publish additional analyses from the results of this trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanzira Zaman, MD principal investigator
Cedars-Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc and Nicotinamide riboside in people with Idiopathic Pulmonary Fibrosis, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (310-423-8474, GroupLungResearch@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Retention (time frame: From study activation to 78 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567717, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.