Trial Outcomes & Findings for Vitamin D3 Supplementation in Patients With HIV: Effects on Interleukin-6 Levels and CD4 Counts (NCT NCT07553052)

Results Overview

The change in serum Interleukin-6 (IL-6) levels from baseline to 3 months after Vitamin D3 supplementation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2026-07-15

Participant Flow

The study population consisted of all patients diagnosed with HIV and receiving ART at Dr. Moewardi General Hospital. Study subjects were selected from this population according to eligibility criteria

This study included 20 patients with HIV receiving ART who were randomly allocated into the Vitamin D3 supplementation group (n=10) and the control group (n=10)

Participant milestones

Participant milestones
Measure	Vitamin D3 + Standard Therapy Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months	Standard Therapy Participants receive standard antiretroviral therapy without Vitamin D3 supplementation
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 + Standard Therapy n=10 Participants Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months	Standard Therapy n=10 Participants Participants receive standard antiretroviral therapy without Vitamin D3 supplementation	Total n=20 Participants Total of all reporting groups
Age, Continuous	40 year STANDARD_DEVIATION 11 • n=10 Participants	47 year STANDARD_DEVIATION 16 • n=10 Participants	43 year STANDARD_DEVIATION 14 • n=20 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	8 Participants n=10 Participants	15 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Indonesia	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
IL-6	86 pg/mL STANDARD_DEVIATION 4 • n=10 Participants	83 pg/mL STANDARD_DEVIATION 2 • n=10 Participants	84 pg/mL STANDARD_DEVIATION 4 • n=20 Participants
CD-4	483 cells/µL STANDARD_DEVIATION 317 • n=10 Participants	154 cells/µL STANDARD_DEVIATION 123 • n=10 Participants	318 cells/µL STANDARD_DEVIATION 288 • n=20 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

The change in serum Interleukin-6 (IL-6) levels from baseline to 3 months after Vitamin D3 supplementation

Outcome measures

Outcome measures
Measure	Vitamin D3 + Standard Therapy n=10 Participants Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months	Standard Therapy n=10 Participants Participants receive standard antiretroviral therapy without Vitamin D3 supplementation
Change in Interleukin-6 (IL-6) Levels	-26 pg/mL) Standard Deviation 1	37 pg/mL) Standard Deviation 2

PRIMARY outcome

Timeframe: Baseline to 3 months

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

Outcome measures

Outcome measures
Measure	Vitamin D3 + Standard Therapy n=10 Participants Participants receive standard antiretroviral therapy plus Vitamin D3 supplementation at a dose of 5000 IU daily for 3 months	Standard Therapy n=10 Participants Participants receive standard antiretroviral therapy without Vitamin D3 supplementation
Change in CD4 Counts	51 cells/µL Standard Deviation 107 • Interval -0.43 to 1.45	8 cells/µL Standard Deviation 50 • Interval -0.43 to 1.45

Adverse Events

Vitamin D3 + Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Resident of Internal Medicine

Faculty of Medicine, Sebelas Maret University/Dr. Moewardi Hospital

Phone: +6281336316650

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place