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Clinical Trials/NCT07553052
NCT07553052CompletedNot Applicable

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

Universitas Sebelas Maret1 site in 1 country20 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in Interleukin-6 (IL-6) Levels

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 59 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Vitamin D3 + Standard Therapy

Experimental

Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months

Intervention: Vitamin D3 (Drug)

Vitamin D3 + Standard Therapy

Experimental

Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months

Intervention: Antiretroviral (ARV) medications (Drug)

Standard Therapy

Active Comparator

Participants receive standard antiretroviral therapy without Vitamin D3 supplementation

Intervention: Antiretroviral (ARV) medications (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dinar Dewi Miftah Tyas Arum

Resident

Universitas Sebelas Maret

Study Sites (1)

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