Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation
研究概览
简要总结
Background:
Psoriasis causes chronic inflammation in the body. Researchers want to see if a kind of vitamin B3 dietary supplement can help. This might lead to more treatment options.
Objective:
To test if the dietary supplement nicotinamide riboside can improve immune system function in the blood and skin of people with mild to moderate psoriasis.
Eligibility:
People ages 18-80 with mild to moderate active psoriasis not currently treated with biological therapy
Design:
Participations will be screened with:
- Medical and medication history
- Physical exam
- Measure of body mass index
- Skin exam
- Blood and urine tests
Participants will have visit 1. They will have repeats of the screening tests. They may also have 2 skin biopsies, which are optional. These will be from both lesions and unaffected areas. The areas will be injected with a numbing medicine. A round cutting device will remove small pieces of skin from each area.
Participants will take the study supplement or a placebo starting at the first visit. Neither participants nor the study team will know which they receive. Participants will take capsules twice daily for a total of 4 weeks.
Participants will then have visit 2. This will include the tests performed at visit 1.
Participants may by contacted by phone or email between visits to see how they are doing.
If participants develop any side effects in the 7 days after they stop taking the capsules, they may have another visit.
详细描述
Study Description:
Psoriasis is a Th17 linked inflammatory disease and we find that the vitamin B3 analogue nicotinamide riboside (NR) blunts Th1 and Th17 activation in ex-vivo na(SqrRoot) ve and differentiated T cells from control and psoriasis subjects. These findings supported the proposal of the following hypothesis. Supplementation with NR will blunt systemic immune activation in mild/moderate psoriasis.
Objectives:
1) Evaluate the effect of NR on Th17 biology
Endpoints:
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 基础科学
- 盲法
- 三盲 (受试者、医护人员、研究者)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Individuals must meet all inclusion criteria listed below in order to be eligible to participate in the study.
- Males and females between the ages of 18 and 80 with mild to moderate active psoriasis.
- Female subjects of child-bearing ability willing to commit to reliable contraception while participating in the study.
- Ability to provide informed consent
- Willingness and ability to participate in required study procedures
排除标准
- Severe psoriasis by PASI (Psoriasis Area and Severity Index) score > 12
- Currently being treated with biologic immune modifying agents.
- Currently on treatment for allergies or other inflammatory diseases.
- Currently taking a multivitamin, Vitamin B or tryptophan supplementation and unwilling to stop within 2 weeks of baseline visit.
- Unwillingness/inability to provide informed consent
- ALT > x3 upper limit of normal, hepatic insufficiency or active liver disease
- Recent history of acute gout
- Chronic renal insufficiency with creatinine > 2.5mg/dl
- Pregnant (or attempting to become pregnant) women
- Current participation in another drug study
- History of intolerance to NR precursor compounds, including niacin or nicotinamide
- Study adherence concerns
- Individuals with diabetes type 1 and 2 who use insulin
- Women of child-bearing potential unwilling to use contraception or unwilling to practice abstinence
- Breastfeeding women unwilling to stop breastfeeding
- Immunization administered within 30 days of participation and no plans for immunization while participating in the study
研究组 & 干预措施
Participants with mild to moderate Psoriasis receiving Placebo
Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.
干预措施: Placebo (Other)
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.
干预措施: Niagen (Dietary Supplement)
方案终点
主要结局
Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation
时间窗: Baseline and Day 28
Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.
次要结局
未报告次要终点
试验结果
结果已于 2023-12-27 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 29 人 · 完成 27 人
主要终点
Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation
pg/mL · Standard Deviation · 时间窗: Baseline and Day 28
| Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside （n=14） | Participants With Mild to Moderate Psoriasis Receiving Placebo （n=11） |
|---|---|
| -176.9 (174.7) | -7.2 (120.9) |
One participant from placebo group not included in analysis due to insufficient T-cells. One participant from Nicotinamide Riboside group not included in analysis due to abnormal lipids.
p = 0.01 · t-test, 2 sided
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | 0 / 17 | 0 / 17 |
| Participants With Mild to Moderate Psoriasis Receiving Placebo | 0 / 12 | 0 / 12 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
相关文献
- 相关文献（PubMed 关联）Han K, Klein RJ, Recupero TC, Russo AC, Sharma R, Gupta AK, Hassanzadeh S, Huffstutler RD, Dagur PK, Fisk B, Redekar NR, Sack MN. NAD+ augmentation by nicotinamide riboside engages SLIT2/ROBO1 signaling to attenuate Th17 inflammation in psoriasis. JCI Insight. 2026 Apr 28;11(12):e203826. doi: 10.1172/jci.insight.203826. eCollection 2026 Jun 22. PubMed 42048163
研究者
研究点 (1)
标识符
- NCT 编号
- NCT04271735
- 其他研究编号
- 200044, 20-H-0044
日期
- 首次提交
- (6年前)
- 首次发布
- (6年前)
- 主要完成日期
- (3年前)
- 研究完成日期
- (3年前)
- 最近核实
- (2个月前)
- 最近更新
- (21天前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 是