Zinc + Nicotinamide Riboside for Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen by Tanzira Zaman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with idiopathic pulmonary fibrosis who can perform study procedures from home. They must be able to take supplements twice daily, do lung function tests every 12 weeks, have a CT scan at the start and end of the study, attend video visits every 4 weeks, and complete symptom surveys.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

I can do lung function and 6-minute walk tests every 3 months.

Confident diagnosis of IPF per the latest ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF

Exclusion Criteria

I started taking pirfenidone or nintedanib less than 60 days ago.

I haven't taken any strong immune or cancer drugs in the last 60 days.

Any condition that in the opinion of the investigators would confound the ability to interpret data from the study

Participant Groups

The trial is testing if zinc and nicotinamide riboside can improve symptoms or lung function in IPF patients. Participants will receive either these supplements or placebos without active ingredients to compare effects over a period of 24 weeks.

Group I: Combination Supplements Experimental Treatment 2 Interventions

Zinc and nicotinamide riboside

Group II: Placebo Placebo Group 1 Intervention

Placebo-controls for both zinc and nicotinamide riboside

Nicotinamide riboside is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Niagen for:

• Dietary supplement for general health and wellness

🇪🇺 Approved in European Union as Tru Niagen for:

• Dietary supplement for general health and wellness

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cedars-Sinai Los Angeles, CA

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center Lead Sponsor

References