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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Supplements | Experimental | Zinc and nicotinamide riboside |
|
| Placebo | Placebo Comparator | Placebo-controls for both zinc and nicotinamide riboside |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Drug | Zinc has not previously been investigated in the treatment of IPF. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Number of participants who are recruited over 52 weeks divided by 60, expressed as a percent | From study activation to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forced vital capacity | Change in the percent-predicted forced vital capacity | From enrollment to 24 weeks |
| Change in 6 minute walk distance | Change in the 6 minute walk distance as expressed in meters |
Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 310-423-8474 | GroupLungResearch@cshs.org | |
| Tanzira Zaman, MD | Contact | 310-423-6303 | Tanzira.Zaman@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Tanzira Zaman, MD | Cedars-Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33385109 | Background | 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. | |
| 29992272 |
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Our study group would like to perform and publish additional analyses from the results of this trial.
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D054988 | Idiopathic Interstitial Pneumonias |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| C018613 | nicotinamide-beta-riboside |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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Statistician
| Placebos for zinc and nicotinamide riboside |
| Other |
These will be identical in appearance to the active substances |
|
| Nicotinamide riboside | Drug | Nicotinamide riboside has not previously been investigated in the treatment of IPF. |
|
| From enrollment to 24 weeks |
| Change in quality of life surveys | Change in the score on the Living with Pulmonary Fibrosis-Symptoms and Living with Pulmonary Fibrosis-Impacts surveys | From enrollment to 24 weeks |
| Change in diffusion capacity of the lung | Change in the percent-predicted diffusion capacity | From enrollment to 24 weeks |
| 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. |
| 31278280 | 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. |
| 33353981 | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |