Human Immunodeficiency Virus (HIV)NCT07553052

Vitamin D3 Supplementation in Patients With HIV: Effects on Interleukin-6 Levels and CD4 Counts

A study testing Vitamin D3 and Antiretroviral (ARV) medications in people with Human Immunodeficiency Virus (HIV), run by Universitas Sebelas Maret at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 59 years
Conditions the study is for: Human Immunodeficiency Virus (HIV)
What is being tested?: Vitamin D3 and Antiretroviral (ARV) medications
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteIndonesia
Study dates: 1 Jun 2025to 30 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Voluntary Counseling and Testing (VCT) Clinic, Dr. Moewardi General Hospital, Surakarta, Indonesia
Surakarta, Central Java, 57126

Other trials in Indonesia

About this study

Official title: 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

Read the 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.

Conditions: Human Immunodeficiency Virus (HIV)
Being tested: Vitamin D3, Antiretroviral (ARV) medications
Keywords: Vitamin D3, HIV, Interleukin-6, CD4
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Drug
Participants receive oral Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months in addition to standard antiretroviral therapy
Antiretroviral (ARV) medicationsDrug
Participants receive standard antiretroviral therapy.

Study groups in NCT07553052
Study group	Role	What they receive
Vitamin D3 + Standard Therapy	Experimental	Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months Receives: Drug: Vitamin D3; Drug: Antiretroviral (ARV) medications
Standard Therapy	Active comparator	Participants receive standard antiretroviral therapy without Vitamin D3 supplementation Receives: Drug: Antiretroviral (ARV) medications

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline to 3 months
Change in CD4 Counts
The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation
Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202530 Sep 2025

First posted27 Apr 2026
Study start1 Jun 2025
Primary completion31 Aug 2025
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07553052
Sponsor's protocol ID: 624/III/HREC/2025
Status last verified: Jun 2026
First submitted: 31 Mar 2026
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: 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.

Publications

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus (HIV) trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07553052
Acronym / sponsor ID: 624/III/HREC/2025
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: Vitamin D3, HIV, Interleukin-6, CD4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Universitas Sebelas MaretUniversity, hospital or other
Collaborators: Dr. Moewardi General Hospital, Surakarta, Indonesia
Study start: 1 Jun 2025 (actual)
Primary completion: 31 Aug 2025 (actual)
Study completion: 30 Sep 2025 (actual)
First posted: 27 Apr 2026 (actual)
Results: Posted 15 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Vitamin D3 + Standard Therapy	Experimental	Drug: Vitamin D3, Drug: Antiretroviral (ARV) medicationsParticipants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months
Standard Therapy	Active comparator	Drug: Antiretroviral (ARV) medicationsParticipants receive standard antiretroviral therapy without Vitamin D3 supplementation

Who may qualify

Ages: 19 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3Participants receive oral Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months in addition to standard antiretroviral therapy	Drug	Vitamin D3 + Standard Therapy
Antiretroviral (ARV) medicationsParticipants receive standard antiretroviral therapy.	Drug	Standard Therapy, Vitamin D3 + Standard Therapy

Primary outcome

Change in Interleukin-6 (IL-6) Levels
Time frame: 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
Time frame: Baseline to 3 months
The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation

Results and safety

Results posted to the registry on 15 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D3 + Standard Therapy	10	10
Standard Therapy	10	10

Primary outcome: Change in Interleukin-6 (IL-6) Levels

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: pg/mL)

Measure	Vitamin D3 + Standard Therapy n = 10	Standard Therapy n = 10
Value	-26 (1)	37 (2)

Primary outcome: Change in CD4 Counts

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: cells/µL

Measure	Vitamin D3 + Standard Therapy n = 10	Standard Therapy n = 10
Value	51 (107)	8 (50)

Adverse events

Time frame: From first dose of study intervention until completion of the 3-month follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin D3 + Standard Therapy	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Standard Therapy	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Limitations include a relatively small sample size, which may have reduced statistical power to detect modest CD4 changes, and a short supplementation period (3 months), which may have been insufficient to observe long-term immune recovery. Serum vitamin D levels were not monitored longitudinally, limiting assessment of dose-response relationships. Potential confounders, including ART adherence, nutritional status, nadir CD4 count, and comorbidities, were not fully controlled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background1. 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.
Individual participant dataSharing planned: Undecided. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 and Antiretroviral (ARV) medications in people with Human Immunodeficiency Virus (HIV), run by Universitas Sebelas Maret at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Interleukin-6 (IL-6) Levels (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07553052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.