Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567717
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of a Decentralized Double-Blind Randomized Controlled Trial of Zinc and Nicotinamide Riboside for the Treatment of Idiopathic Pulmonary Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None