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RecruitingNCT06567717Updated Nov 10, 2025

Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis

A Phase 2 interventional study of Zinc and Placebos for zinc and nicotinamide riboside in Idiopathic Pulmonary Fibrosis, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by Cedars-Sinai Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • ipf
  • pulmonary fibrosis
  • idiopathic pulmonary fibrosis
03

In context

Idiopathic Pulmonary Fibrosis

551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's planned enrollment of 60 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 442 studies on the registry; 109 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 \&gt; 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Combination Supplements

    Zinc and nicotinamide riboside

    Drug: Zinc · Drug: Nicotinamide riboside

  • Placebo comparator
    Placebo

    Placebo-controls for both zinc and nicotinamide riboside

    Other: Placebos for zinc and nicotinamide riboside

Interventions

  • DrugZinc

    Zinc has not previously been investigated in the treatment of IPF.

  • OtherPlacebos for zinc and nicotinamide riboside

    These will be identical in appearance to the active substances

  • DrugNicotinamide riboside

    Nicotinamide riboside has not previously been investigated in the treatment of IPF.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: From study activation to 52 weeks

Other outcomes

  1. Change in forced vital capacity

    Change in the percent-predicted forced vital capacity

    Time frame: From enrollment to 24 weeks

  2. Change in 6 minute walk distance

    Change in the 6 minute walk distance as expressed in meters

    Time frame: From enrollment to 24 weeks

  3. Change in quality of life surveys

    Change in the score on the Living with Pulmonary Fibrosis-Symptoms and Living with Pulmonary Fibrosis-Impacts surveys

    Time frame: From enrollment to 24 weeks

  4. Change in diffusion capacity of the lung

    Change in the percent-predicted diffusion capacity

    Time frame: From enrollment to 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Cedars-Sinai
    Los Angeles, California 90048, United States
    Recruiting
08

References and documents

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 33385109 ↗
  • Dollerup 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 29992272 ↗
  • Conze 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 31278280 ↗
  • Covarrubias 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 ↗

Individual participant data

Plan to share: No — Our study group would like to perform and publish additional analyses from the results of this trial.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06567717
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Tanzira Zaman (Principal Investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Aug 23, 2024
Start date
Nov 3, 2025
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Nov 10, 2025

Study contacts

Study Coordinator
Contact
GroupLungResearch@cshs.org
310-423-8474
Tanzira Zaman, MD
Contact
Tanzira.Zaman@cshs.org
310-423-6303
Tanzira Zaman, MD
principal investigator · Cedars-Sinai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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