HealthyNCT06491979
Vitamin and Unsaturated Fatty Acid Supplements in Healthy and Uveitis Human Subjects
A study testing Vitamin A treatment, Monounsaturated fatty acid mixture and Polyunsaturated fatty acid mixture in people with Healthy and Uveitis, run by Tianjin Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Uveitis, Autoimmune Diseases
- What is being tested?
- Vitamin A treatment, Monounsaturated fatty acid mixture and Polyunsaturated fatty acid mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy or with uveitis volunteers age 19-65 years.
Who cannot join
- abnormal blood glucose, blood pressure, blood lipids, or other systemic diseases should not participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300071
About this study
Official title: 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.
- Conditions
- Healthy, Uveitis, Autoimmune Diseases
- Being tested
- Vitamin A treatment, Monounsaturated fatty acid mixture, Polyunsaturated fatty acid mixture, Fatty acid mixture
- Medical subject headings
- Uveitis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A treatmentDietary supplement
Vitamin A, 32 microgram per kilograms (of body weight) per day, for three weeks
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A treatment | Experimental | Not described Receives: Dietary Supplement: Vitamin A treatment |
| Monounsaturated fatty acid mixture | Experimental | Not described Receives: Dietary Supplement: Monounsaturated fatty acid mixture |
| Polyunsaturated fatty acid mixture | Experimental | Not described Receives: Dietary Supplement: Polyunsaturated fatty acid mixture |
| Fatty acid mixture | Experimental | Not described Receives: Dietary Supplement: Fatty acid mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 weeks
Secondary outcomes (8)
Cytokine levels-Interleukin-17A (IL-17A)
Analysis of cytokine levels in blood. Detect the concention of Interleukin-17A (IL-17A) in plasma
Measured: 3 weeks
Cytokine levels-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Analysis of cytokine levels in blood. Detect the concention of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in plasma
Measured: 3 weeks
Cytokine levels-Interferon gamma (IFN-γ)
Analysis of cytokine levels in blood. Detect the concention of Interferon gamma (IFN-γ) in plasma
Measured: 3 weeks
Cytokine levels-Interleukin-2 (IL-2)
Analysis of cytokine levels in blood. Detect the concention of Interleukin-2 (IL-2) in plasma
Measured: 3 weeks
Cytokine levels-Interleukin-10 (IL-10)
Analysis of cytokine levels in blood. Detect the concention of Interleukin-10 (IL-10) in plasma
Measured: 3 weeks
Cytokine levels-Interleukin-9 (IL-9)
Analysis of cytokine levels in blood. Detect the concention of Interleukin-9 (IL-9) in plasma
Measured: 3 weeks
Cytokine levels-Interleukin-4 (IL-4)
Analysis of cytokine levels in blood. Detect the concention of Interleukin-4 (IL-4) in plasma
Measured: 3 weeks
Cytokine levels-Tumor Necrosis Factor alpha (TNF-α)
Analysis of cytokine levels in blood. Detect the concention of Tumor Necrosis Factor alpha (TNF-α) in plasma
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Jul 2024
- Primary completion17 Aug 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Zhang, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491979
- Sponsor's protocol ID
- 2023KY-54
- Status last verified
- Nov 2024
- First submitted
- 1 Jul 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study on the Treatment of Uveitis With Vitamin and Unsaturated Fatty Acid Combination Dietary Supplements Through Modulating T Cell Function
- ClinicalTrials.gov ID
- NCT06491979
- Acronym / sponsor ID
- 2023KY-54
- Conditions
- Healthy, Uveitis, Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy or with uveitis volunteers age 19-65 years.
Key exclusion criteria (1 listed)
- abnormal blood glucose, blood pressure, blood lipids, or other systemic diseases should not participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A treatmentVitamin A, 32 microgram per kilograms (of body weight) per day, for three weeks | Dietary supplement | Vitamin A treatment |
| Monounsaturated fatty acid mixtureMonounsaturated fatty acid mixture (mainly Omega-7, Omega-9), 47 milligrams per kilogram (of body weight) per day, for three weeks | Dietary supplement | Monounsaturated fatty acid mixture |
| Polyunsaturated fatty acid mixturePolyunsaturated fatty acid mixture (mainly Omega-3, Omega-6), 6 milligrams per kilogram (of body weight) per day, for three weeks | Dietary supplement | Polyunsaturated fatty acid mixture |
| Fatty acid mixtureFatty acid mixture (mainly saturated fatty acid, Omega-6, Omega-7, Omega-9), 83 milligrams per kilogram (of body weight) per day, for three weeks | Dietary supplement | Fatty acid mixture |
Primary outcome
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
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
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
8 secondary outcomes
Cytokine levels-Interleukin-17A (IL-17A)
Time frame: 3 weeks
Cytokine levels-Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Time frame: 3 weeks
Cytokine levels-Interferon gamma (IFN-γ)
Time frame: 3 weeks
Cytokine levels-Interleukin-2 (IL-2)
Time frame: 3 weeks
Cytokine levels-Interleukin-10 (IL-10)
Time frame: 3 weeks
Cytokine levels-Interleukin-9 (IL-9)
Time frame: 3 weeks
Cytokine levels-Interleukin-4 (IL-4)
Time frame: 3 weeks
Cytokine levels-Tumor Necrosis Factor alpha (TNF-α)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A treatment, Monounsaturated fatty acid mixture and Polyunsaturated fatty acid mixture in people with Healthy and Uveitis, run by Tianjin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory factors-Interleukin-17A (IL-17A) (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.