Human Immunodeficiency Virus (HIV)
Conditions
Keywords
Vitamin D3, HIV, Interleukin-6, CD4
Brief summary
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.
Detailed description
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.
Interventions
DRUGVitamin D3
Participants receive oral Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months in addition to standard antiretroviral therapy
Participants receive standard antiretroviral therapy.
Sponsors
Universitas Sebelas Maret
Dr. Moewardi General Hospital, Surakarta, Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients who discontinue treatment (dropout) or die during the study period * Patients who experience allergic reactions to Vitamin D3 supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin-6 (IL-6) Levels | 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 | Baseline to 3 months | The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation |
Countries
Indonesia
Outcome results
None listed