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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

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)

July 15, 2024

Primary Completion (Actual)

August 17, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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