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| Name | Class |
|---|---|
| Dr. Moewardi General Hospital, Surakarta, Indonesia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 + Standard Therapy | Experimental | Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months |
|
| Standard Therapy | Active Comparator | Participants receive standard antiretroviral therapy without Vitamin D3 supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Participants receive oral Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months in addition to standard antiretroviral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-6 (IL-6) Levels | The change in serum Interleukin-6 (IL-6) levels from baseline to 3 months after Vitamin D3 supplementation | Baseline to 3 months |
| Change in CD4 Counts | The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation | Baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Voluntary Counseling and Testing (VCT) Clinic, Dr. Moewardi General Hospital, Surakarta, Indonesia | Surakarta | Central Java | 57126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Wong K, Nguyen J, Blair L, Banjanin M, Grewal B, Bowman S, et al. Pathogenesis of Human Immunodeficiency Virus-Mycobacterium tuberculosis Co-Infection. J Clin Med. 2020;9(11):3575. 2. Ron R, Moreno E, MartÃnez-Sanz J, Brañas F, Sainz T, Moreno S, et al. CD4/CD8 Ratio During Human Immunodeficiency Virus Treatment: Time for Routine Monitoring? Clinical Infectious Diseases. 2023;76(9):1688-96. 3. Velazquez-Salinas L, Verdugo-Rodriguez A, Rodriguez LL, Borca M V. The Role of Interleukin 6 During Viral Infections. Front Microbiol. 2019;10. doi:10.3389/fmicb.2019.01057 4. Visuthranukul J, Phansuea P, Buranakityanon P, Lerdrungroj P, Yamasmith E. Prevalence and risk factors of vitamin D deficiency among living with HIV adults receiving antiretroviral treatment in tropical area: Cross-sectional study. Heliyon. 2023;9:e19537. 5. Alvarez N, Aguilar-Jimenez W, Rugeles MT. The Potential Protective Role of Vitamin D Supplementation on HIV-1 Infection. Front Immunol. 2019;10:2291. 6. Pitman MC, Meagher N, Price DJ, Rhodes A, Chang JJ, Scher B, et al. Effect of high dose vitamin D3 on the HIV-1 reservoir: A pilot randomised controlled trial. J Virus Erad. 2023;9(3):100345. doi:https://doi.org/10.1016/j.jve.2023.100345 7. Zhang J, Guan J, Niu X, Hu G, Guo S, Li Q, et al. Exosomes released from human induced pluripotent stem cells-derived MSCs facilitate cutaneous wound healing by promoting collagen synthesis and angiogenesis. J Transl Med. 2015;13(1):1-14. 8. Trovato M, Ruggeri RM, Sciacchitano S, Vicchio TM, Picerno I, Pellicanò G, et al. Serum interleukin-6 levels are increased in HIV-infected patients that develop autoimmune disease during long-term follow-up. Immunobiology. 2018;223(3):264-8. doi:https://doi.org/10.1016/j.imbio.2017.10.039 9. Teixeira NDSCCA, Pereira BM, Oliveira IKF, Lima CHR, Carvalho CMRG, Nunes IFOC, et al. Effect of vitamin D3 supplementation on HIV-infected adults: a systematic review Vitamin DÓ¡. Nutr Hosp. 2019;36(5):1205-1212. |
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There is a potential plan to share individual participant data, as this study is part of a broader umbrella research project. However, to date, the data have not yet been managed or accessed by other research teams. If data sharing is undertaken, de-identified baseline participant characteristics will be made available in the form of an Excel file upon reasonable request via email. Access will be granted to researchers who provide a methodologically sound proposal, subject to approval by the research team and in accordance with institutional and ethical regulations. Data sharing will require a formal request and agreement to ensure confidentiality and appropriate use of the data.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 10, 2026 | |
| Unrelease | May 20, 2026 | |
| Release | May 20, 2026 | |
| Reset | Jun 16, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 24, 2025 | Apr 22, 2026 | Prot_SAP_ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 10, 2026 | May 20, 2026 | |||
| May 20, 2026 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D044966 | Anti-Retroviral Agents |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Antiretroviral (ARV) medications | Drug | Participants receive standard antiretroviral therapy. |
|
| Jun 16, 2026 |
| Jun 17, 2026 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000998 | Antiviral Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |