NCT06491979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

July 1, 2024

Last Update Submit

November 5, 2024

Conditions

HealthyUveitisAutoimmune Diseases

Outcome Measures

Primary Outcomes (3)

  • Inflammatory factors-Interleukin-17A (IL-17A)

    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)

    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)

    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 Outcomes (8)

  • Cytokine levels-Interleukin-17A (IL-17A)

    3 weeks

  • Cytokine levels-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

    3 weeks

  • Cytokine levels-Interferon gamma (IFN-γ)

    3 weeks

  • Cytokine levels-Interleukin-2 (IL-2)

    3 weeks

  • Cytokine levels-Interleukin-10 (IL-10)

    3 weeks

  • +3 more secondary outcomes

Other Outcomes (4)

  • Transcriptomics analysis

    3 weeks

  • Proteomics analysis

    3 weeks

  • post-translational modification proteomics analysis

    3 weeks

  • +1 more other outcomes

Study Arms (4)

Vitamin A treatment

EXPERIMENTAL
Dietary Supplement: Vitamin A treatment

Monounsaturated fatty acid mixture

EXPERIMENTAL
Dietary Supplement: Monounsaturated fatty acid mixture

Polyunsaturated fatty acid mixture

EXPERIMENTAL
Dietary Supplement: Polyunsaturated fatty acid mixture

Fatty acid mixture

EXPERIMENTAL
Dietary Supplement: Fatty acid mixture

Interventions

Vitamin A treatmentDIETARY_SUPPLEMENT

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

Vitamin A treatment
Monounsaturated fatty acid mixtureDIETARY_SUPPLEMENT

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

Monounsaturated fatty acid mixture
Polyunsaturated fatty acid mixtureDIETARY_SUPPLEMENT

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

Polyunsaturated fatty acid mixture
Fatty acid mixtureDIETARY_SUPPLEMENT

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

Fatty acid mixture

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300071, China

Location

MeSH Terms

Conditions

UveitisAutoimmune Diseases

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

July 15, 2024

Primary Completion

August 17, 2024

Study Completion

October 31, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations

CN(1)