Vitamin and Unsaturated Fatty Acid Supplements in Healthy and Uveitis Human Subjects

November 5, 2024 updated by: Xiaomin Zhang, Tianjin Medical University

Interventional Study on the Treatment of Uveitis With Vitamin and Unsaturated Fatty Acid Combination Dietary Supplements Through Modulating T Cell Function

The goal of this clinical trial is to learn if dietary supplements containing vitamin and unsaturated fatty acid works to intervene T cell inflammatory factor expression in patients with uveitis and healthy subjects in adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300071
        • Tianjin Medical University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy or with uveitis volunteers age 19-65 years.

Exclusion Criteria:

  • abnormal blood glucose, blood pressure, blood lipids, or other systemic diseases should not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vitamin A treatment
Dietary supplement: Vitamin A treatment
Vitamin A, 32 microgram per kilograms (of body weight) per day, for three weeks
Experimental: Monounsaturated fatty acid mixture
Dietary supplement: Monounsaturated fatty acid mixture
Monounsaturated fatty acid mixture (mainly Omega-7, Omega-9), 47 milligrams per kilogram (of body weight) per day, for three weeks
Experimental: Polyunsaturated fatty acid mixture
Dietary supplement: Polyunsaturated fatty acid mixture
Polyunsaturated fatty acid mixture (mainly Omega-3, Omega-6), 6 milligrams per kilogram (of body weight) per day, for three weeks
Experimental: Fatty acid mixture
Dietary supplement: Fatty acid mixture
Fatty acid mixture (mainly saturated fatty acid, Omega-6, Omega-7, Omega-9), 83 milligrams per kilogram (of body weight) per day, for three weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inflammatory factors-Interleukin-17A (IL-17A)
Time Frame: 3 weeks
Flow cytometry analysis of peripheral blood mononuclear cells (PBMCs) to detect the ratio of Interleukin-17A (IL-17A) -producing cells in CD4+ T cells and CD8+ T cells
3 weeks
Inflammatory factors-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Time Frame: 3 weeks
Flow cytometry analysis of peripheral blood mononuclear cells (PBMCs) to detect the ratio of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) -producing cells in CD4+ T cells and CD8+ T cells
3 weeks
Inflammatory factors-Interferon gamma (IFN-γ)
Time Frame: 3 weeks
Flow cytometry analysis of peripheral blood mononuclear cells (PBMCs) to detect the ratio of Interferon gamma (IFN-γ) -producing cells in CD4+ T cells and CD8+ T cells
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cytokine levels-Interleukin-17A (IL-17A)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Interleukin-17A (IL-17A) in plasma
3 weeks
Cytokine levels-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in plasma
3 weeks
Cytokine levels-Interferon gamma (IFN-γ)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Interferon gamma (IFN-γ) in plasma
3 weeks
Cytokine levels-Interleukin-2 (IL-2)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Interleukin-2 (IL-2) in plasma
3 weeks
Cytokine levels-Interleukin-10 (IL-10)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Interleukin-10 (IL-10) in plasma
3 weeks
Cytokine levels-Interleukin-9 (IL-9)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Interleukin-9 (IL-9) in plasma
3 weeks
Cytokine levels-Interleukin-4 (IL-4)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Interleukin-4 (IL-4) in plasma
3 weeks
Cytokine levels-Tumor Necrosis Factor alpha (TNF-α)
Time Frame: 3 weeks
Analysis of cytokine levels in blood. Detect the concention of Tumor Necrosis Factor alpha (TNF-α) in plasma
3 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transcriptomics analysis
Time Frame: 3 weeks
Analyze the changes in peripheral blood mononuclear cells using transcriptomics. Detect the cell populations , genes number and expression.
3 weeks
Proteomics analysis
Time Frame: 3 weeks
Analyze the changes in peripheral blood mononuclear cells using proteomics. Detect the proteins expression.
3 weeks
post-translational modification proteomics analysis
Time Frame: 3 weeks
Analyze the changes in peripheral blood mononuclear cells using post-translational modification proteomics. Detect the protein various modification, such as lactylation, crotonylation, palmitoylation and methylation.
3 weeks
metabolomics analysis
Time Frame: 3 weeks
Analyze the changes in peripheral blood mononuclear cells using metabolomics. Detect the metabolites numbers, localization and level.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023KY-54

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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