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

June 17, 2026 updated by: Dinar Dewi Miftah Tyas Arum, Universitas Sebelas Maret

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vitamin D3 + Standard Therapy
Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months
Drug: Vitamin D3
Participants receive oral Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months in addition to standard antiretroviral therapy
Drug: Antiretroviral (ARV) medications
Participants receive standard antiretroviral therapy.
Active Comparator: Standard Therapy
Participants receive standard antiretroviral therapy without Vitamin D3 supplementation
Drug: Antiretroviral (ARV) medications
Participants receive standard antiretroviral therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 3 months
Change in CD4 Counts
Time Frame: Baseline to 3 months
The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitas Sebelas Maret

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dr. Moewardi General Hospital, Surakarta, Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 624/III/HREC/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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