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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06491979
Enrollment
7
Registered
2024-07-09
Start date
2024-07-15
Completion date
2024-10-31
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Healthy, Uveitis

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTVitamin A treatment

Vitamin A, 32 microgram per kilograms (of body weight) per day, for three weeks

DIETARY_SUPPLEMENTMonounsaturated fatty acid mixture

Monounsaturated fatty acid mixture (mainly Omega-7, Omega-9), 47 milligrams per kilogram (of body weight) per day, for three weeks

DIETARY_SUPPLEMENTPolyunsaturated fatty acid mixture

Polyunsaturated fatty acid mixture (mainly Omega-3, Omega-6), 6 milligrams per kilogram (of body weight) per day, for three weeks

DIETARY_SUPPLEMENTFatty 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

Sponsors

Tianjin Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory factors-Interferon gamma (IFN-γ)3 weeksFlow 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
Inflammatory factors-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)3 weeksFlow 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
Inflammatory factors-Interleukin-17A (IL-17A)3 weeksFlow 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

Secondary

MeasureTime frameDescription
Cytokine levels-Interferon gamma (IFN-γ)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Interferon gamma (IFN-γ) in plasma
Cytokine levels-Interleukin-2 (IL-2)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Interleukin-2 (IL-2) in plasma
Cytokine levels-Interleukin-17A (IL-17A)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Interleukin-17A (IL-17A) in plasma
Cytokine levels-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in plasma
Cytokine levels-Interleukin-10 (IL-10)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Interleukin-10 (IL-10) in plasma
Cytokine levels-Interleukin-9 (IL-9)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Interleukin-9 (IL-9) in plasma
Cytokine levels-Interleukin-4 (IL-4)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Interleukin-4 (IL-4) in plasma
Cytokine levels-Tumor Necrosis Factor alpha (TNF-α)3 weeksAnalysis of cytokine levels in blood. Detect the concention of Tumor Necrosis Factor alpha (TNF-α) in plasma

Other

MeasureTime frameDescription
Transcriptomics analysis3 weeksAnalyze the changes in peripheral blood mononuclear cells using transcriptomics. Detect the cell populations , genes number and expression.
Proteomics analysis3 weeksAnalyze the changes in peripheral blood mononuclear cells using proteomics. Detect the proteins expression.
metabolomics analysis3 weeksAnalyze the changes in peripheral blood mononuclear cells using metabolomics. Detect the metabolites numbers, localization and level.
post-translational modification proteomics analysis3 weeksAnalyze the changes in peripheral blood mononuclear cells using post-translational modification proteomics. Detect the protein various modification, such as lactylation, crotonylation, palmitoylation and methylation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026