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Zinc + Nicotinamide Riboside for Pulmonary Fibrosis
Phase 2
Waitlist Available
Led By Tanzira Zaman, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Under active treatment for IPF by a local pulmonologist
Age > 50 years
Must not have
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Any comorbid condition that is likely to result in death within the next year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study activation to 78 weeks
Summary
This trial aims to see if people with idiopathic pulmonary fibrosis (IPF) can participate in a clinical trial from their homes. They will be given a combination of zinc and nicotinamide
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, generally zinc may cause nausea or stomach upset, and nicotinamide riboside could potentially lead to mild discomfort like bloating or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently being treated for IPF by a lung specialist.
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I am over 50 years old.
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My lung scan shows a pattern of UIP.
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My lung biopsy shows a pattern consistent with UIP.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't need frequent procedures to remove excess fluid from my body.
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I do not have any health conditions expected to cause death within a year.
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I take more than 10 mg of prednisone daily.
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I am not on long-term medications that interact with zinc.
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I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.
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My lung function tests show severe restrictions.
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I have had a previous transplant of stem cells or an organ.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study activation to 78 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study activation to 78 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Retention
Secondary study objectives
Recruitment Rate
Other study objectives
Change in 6 minute walk distance
Change in diffusion capacity of the lung
Change in forced vital capacity
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Combination SupplementsExperimental Treatment2 Interventions
Zinc and nicotinamide riboside
Group II: PlaceboPlacebo Group1 Intervention
Placebo-controls for both zinc and nicotinamide riboside
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinc
2005
Completed Phase 4
~16490
Nicotinamide riboside
2021
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,304 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
24 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Tanzira Zaman, MDPrincipal InvestigatorCedars-Sinai
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
24 Patients Enrolled for Idiopathic Pulmonary Fibrosis