跳至主要内容
临床试验/NCT07553052
NCT07553052已完成不适用

The Effect of Vitamin D3 Supplementation on Interleukin-6 Levels and Cluster of Differentiation 4 Counts in Patients With Human Immunodeficiency Virus Receiving Antiretroviral Therapy

Universitas Sebelas Maret1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in Interleukin-6 (IL-6) Levels

研究概览

简要总结

This study aims to evaluate the effect of Vitamin D3 supplementation on inflammatory markers and immune status in patients with HIV who are receiving antiretroviral therapy. Participants will receive Vitamin D3 supplementation for 3 months. Outcomes including Interleukin-6 levels and CD4 counts will be measured to assess the potential benefits of this intervention.

详细描述

Human immunodeficiency virus (HIV) infection is characterized by persistent immune activation and chronic inflammation, which may continue despite effective antiretroviral therapy (ART). Elevated levels of pro-inflammatory cytokines, such as interleukin-6 (IL-6), have been associated with disease progression, immune dysfunction, and increased morbidity in individuals living with HIV.

Vitamin D3 has been recognized for its immunomodulatory and anti-inflammatory properties. It plays a role in both innate and adaptive immune responses, including the regulation of T-cell function and cytokine production. Several studies suggest that Vitamin D deficiency is common among patients with HIV and may contribute to impaired immune recovery and ongoing inflammation despite ART.

This study is designed to evaluate the effect of Vitamin D3 supplementation on inflammatory and immunological parameters in patients with HIV receiving antiretroviral therapy. Participants will receive oral Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months. The primary outcomes include changes in Interleukin-6 (IL-6) levels and CD4 counts, which serve as indicators of systemic inflammation and immune status, respectively.

The findings of this study are expected to provide further evidence regarding the potential role of Vitamin D3 as an adjunctive therapy in improving immune function and reducing inflammation in patients with HIV. This may contribute to the development of more comprehensive management strategies for individuals living with HIV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with HIV stage 1 or 2 who have been receiving antiretroviral therapy (ART) with a TLD regimen for at least 6 months at Dr. Moewardi General Hospital, Surakarta, Indonesia
  • Age 19 to 59 years
  • Willing to participate in the study and provide informed consent
  • Not currently taking any other vitamin supplements

排除标准

  • Patients who discontinue treatment (dropout) or die during the study period
  • Patients who experience allergic reactions to Vitamin D3 supplementation

研究组 & 干预措施

Vitamin D3 + Standard Therapy

Experimental

Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months

干预措施: Vitamin D3 (Drug)

Vitamin D3 + Standard Therapy

Experimental

Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months

干预措施: Antiretroviral (ARV) medications (Drug)

Standard Therapy

Active Comparator

Participants receive standard antiretroviral therapy without Vitamin D3 supplementation

干预措施: Antiretroviral (ARV) medications (Drug)

结局指标

主要结局

Change in Interleukin-6 (IL-6) Levels

时间窗: Baseline to 3 months

The change in serum Interleukin-6 (IL-6) levels from baseline to 3 months after Vitamin D3 supplementation

Change in CD4 Counts

时间窗: Baseline to 3 months

The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dinar Dewi Miftah Tyas Arum

Resident

Universitas Sebelas Maret

研究点 (1)

Loading locations...

相似试验