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Completed

NCT Number: NCT07553052

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

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.

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Key information

Age range

19 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Surakarta, Central Java, 57126, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Antiretroviral (ARV) medications

Drug

Participants receive standard antiretroviral therapy.

Primary outcomes

  1. 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

  2. Change in CD4 Counts

    Time frame: Baseline to 3 months

    The change in CD4 count from baseline to 3 months after Vitamin D3 supplementation

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Collaborators

  • Dr. Moewardi General Hospital, Surakarta, Indonesia

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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