Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis

NCT06567717 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Zn-NR-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

ipf; pulmonary fibrosis; idiopathic pulmonary fibrosis

Outcome Measures

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

  From study activation to 78 weeks

Secondary Outcomes (1)

• Recruitment Rate

  From study activation to 52 weeks

Other Outcomes (4)

• Change in forced vital capacity

  From enrollment to 24 weeks

• Change in 6 minute walk distance

  From enrollment to 24 weeks

• Change in quality of life surveys

  From enrollment to 24 weeks

Study Arms (2)

Combination Supplements

EXPERIMENTAL

Zinc and nicotinamide riboside

Drug: Zinc; Drug: Nicotinamide riboside

Placebo

PLACEBO COMPARATOR

Placebo-controls for both zinc and nicotinamide riboside

Other: Placebos for zinc and nicotinamide riboside

Interventions

Zinc DRUG

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

Combination Supplements

Placebos for zinc and nicotinamide riboside OTHER

These will be identical in appearance to the active substances

Placebo

Nicotinamide riboside DRUG

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

Combination Supplements

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \> 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:

• 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 \> 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 33385109 BACKGROUND

• 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.

  PMID: 29992272 BACKGROUND

• 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.

  PMID: 31278280 BACKGROUND

• 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.

  PMID: 33353981 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias; Pulmonary Fibrosis

Interventions

Zinc; nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Tanzira Zaman, MD

  Cedars-Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

310-423-8474; GroupLungResearch@cshs.org

Tanzira Zaman, MD

CONTACT

310-423-6303; Tanzira.Zaman@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 23, 2024
• Study Start: November 3, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)