Vitamin D3 Supplementation in Patients With HIV: Effects on Interleukin-6 Levels and CD4 Counts
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedFirst Submitted
Initial submission to the registry
March 31, 2026
CompletedFirst Posted
Study publicly available on registry
April 27, 2026
CompletedApril 27, 2026
April 1, 2026
3 months
March 31, 2026
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Vitamin D3 + Standard Therapy
EXPERIMENTALParticipants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months
Standard Therapy
ACTIVE COMPARATORParticipants receive standard antiretroviral therapy without Vitamin D3 supplementation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who discontinue treatment (dropout) or die during the study period
- Patients who experience allergic reactions to Vitamin D3 supplementation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Voluntary Counseling and Testing (VCT) Clinic, Dr. Moewardi General Hospital, Surakarta, Indonesia
Surakarta, Central Java, 57126, Indonesia
Related Publications (1)
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, Martínez-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 Dӡ. Nutr Hosp. 2019;36(5):1205-1212.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 27, 2026
Study Start
June 1, 2025
Primary Completion
August 31, 2025
Study Completion
September 30, 2025
Last Updated
April 27, 2026
Record last verified: 2026-04