Pulmonary TuberculosisNCT07907094
Vitamin D3 and Monocyte Responses in Pregnant Women With Pulmonary Tuberculosis
A study testing Vitamin D3 (Cholecalciferol) and Standard First-Line Anti-Tuberculosis Treatment in people with Pulmonary Tuberculosis and Pregnancy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This randomized controlled trial evaluated the effects of adjunctive vitamin D3 supplementation on circulating monocyte subsets and the expression of vitamin D receptor (VDR) and interleukin-6 (IL-6) in pregnant women with pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pulmonary Tuberculosis, Pregnancy
- What is being tested?
- Vitamin D3 (Cholecalciferol) and Standard First-Line Anti-Tuberculosis Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women at 28-32 weeks of gestation.
- Diagnosed with pulmonary tuberculosis or receiving first-line anti-tuberculosis treatment.
- Willing to participate in the study and provide written informed consent.
Who cannot join
- Extrapulmonary tuberculosis.
- History of abortion, stillbirth, intrauterine fetal death, or previous placental disorders.
- History of autoimmune disease.
- History of cardiovascular disease or current treatment for a cardiovascular condition.
- History of kidney disease.
- History of liver dysfunction.
- History of hematological disorders or coagulation abnormalities.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Persahabatan
Jakarta, Jakarta Special Capital Region, 13220
About this study
Official title: Effects of Adjunctive Vitamin D3 Supplementation on Monocyte Subsets and Expression of Vitamin D Receptor and Interleukin-6 in Pregnant Women With Pulmonary Tuberculosis: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of adjunctive vitamin D3 supplementation on circulating monocyte subsets and the expression of vitamin D receptor (VDR) and interleukin-6 (IL-6) in pregnant women with pulmonary tuberculosis.
A total of 32 pregnant women with pulmonary tuberculosis were allocated to receive either standard first-line anti-tuberculosis treatment alone or standard treatment plus oral vitamin D3 supplementation at a dose of 50,000 IU once weekly for eight weeks.
Read more
Serum 25-hydroxyvitamin D [25(OH)D] concentrations, monocyte subset distributions, and monocyte expression of VDR and IL-6 were assessed at baseline, approximately eight weeks after enrollment, and during the early postpartum period. Monocyte subsets were characterized by CD14 and CD16 expression using flow cytometry.
The study aimed to investigate whether adjunctive vitamin D3 supplementation modifies vitamin D status and monocyte-related immunological responses in pregnant women receiving treatment for pulmonary tuberculosis.
Read the detailed description
Tuberculosis during pregnancy represents an important clinical challenge because both Mycobacterium tuberculosis infection and pregnancy are associated with changes in maternal immune responses. Vitamin D is involved in the regulation of innate immunity, including monocyte and macrophage function. However, the effects of vitamin D3 supplementation on monocyte phenotypes and inflammatory marker expression in pregnant women with pulmonary tuberculosis remain insufficiently understood.
This study was designed as a two-arm randomized controlled trial conducted at Persahabatan General Hospital, Jakarta, Indonesia. Eligible pregnant women with pulmonary tuberculosis were consecutively recruited and allocated to either a control group receiving standard first-line anti-tuberculosis treatment or an intervention group receiving the same treatment supplemented with oral vitamin D3 at 50,000 IU once weekly for eight weeks.
Standard anti-tuberculosis treatment consisted of daily rifampicin, isoniazid, pyrazinamide, and ethambutol during the initial two months, followed by daily rifampicin and isoniazid for four months.
Blood samples were collected at baseline (T1), approximately eight weeks after baseline (T2; allowable window of 6-10 weeks), and during the early postpartum period (T3; postpartum days 7-14).
Serum 25(OH)D concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). Monocyte subsets were characterized using flow cytometry based on CD14 and CD16 expression and classified as classical, intermediate, or nonclassical monocytes. The relative distribution of classical and nonclassical monocytes was additionally evaluated using a logarithmically transformed classical-to-nonclassical monocyte ratio.
Intracellular IL-6 and VDR expression were assessed by flow cytometry, including the percentage of marker-positive monocytes and fluorescence intensity measurements.
Longitudinal analyses evaluated changes across the three assessment points using linear mixed models with treatment group, time, and their interaction as fixed effects. Additional analyses evaluated baseline-to-week-8 changes in monocyte markers, including exploratory analyses stratified by gestational age at enrollment.
The study was primarily designed to investigate laboratory and immunological responses rather than clinical tuberculosis treatment outcomes. Obstetric and neonatal outcomes were also documented descriptively.
- Conditions
- Pulmonary Tuberculosis, Pregnancy
- Being tested
- Vitamin D3 (Cholecalciferol), Standard First-Line Anti-Tuberculosis Treatment
- Keywords
- Vitamin D3, Cholecalciferol, Pulmonary Tuberculosis, Pregnancy, Monocyte Subsets, Vitamin D Receptor, Interleukin-6, Innate Immunity
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
Oral cholecalciferol (vitamin D3), 50,000 international units (IU) once weekly for eight weeks, administered as an adjunct to standard first-line anti-tuberculosis treatment.
Standard First-Line Anti-Tuberculosis TreatmentDrug
Standard first-line anti-tuberculosis treatment consisting of daily rifampicin, isoniazid, pyrazinamide, and ethambutol during the initial two months, followed by daily rifampicin and isoniazid for four months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard TB Treatment | Active comparator | Participants received standard first-line anti-tuberculosis treatment consisting of daily rifampicin, isoniazid, pyrazinamide, and ethambutol for two months, followed by daily rifampicin and isoniazid for four months, without additional study-provided vitamin D3 supplementation. Receives: Drug: Standard First-Line Anti-Tuberculosis Treatment |
| Arm 2 - Vitamin D3 Plus Standard TB Treatment | Experimental | Participants received standard first-line anti-tuberculosis treatment and adjunctive oral vitamin D3 supplementation at a dose of 50,000 IU once weekly for eight consecutive weeks. Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol); Drug: Standard First-Line Anti-Tuberculosis Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum 25-Hydroxyvitamin D Concentration From Baseline to Week 8 Copy
Change in serum 25-hydroxyvitamin D [25(OH)D] concentration, expressed in ng/mL, from baseline to approximately eight weeks after enrollment. Serum 25(OH)D concentrations were measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and approximately 8 weeks after enrollment (6-10-week assessment window).
Secondary outcomes (3)
Change in Classical-to-Nonclassical Monocyte Ratio
The logarithmically transformed ratio of classical (CD14++/CD16-) to nonclassical (CD14+/CD16++) monocyte proportions, measured by flow cytometry.
Measured: Baseline, approximately 8 weeks, and postpartum days 7-14.
Change in IL-6-Positive Monocyte Proportion
Percentage of circulating monocytes expressing intracellular interleukin-6 (IL-6), determined by flow cytometry.
Measured: Baseline, approximately 8 weeks, and postpartum days 7-14.
Change in VDR-Positive Monocyte Proportion
Percentage of circulating monocytes expressing vitamin D receptor (VDR), determined by flow cytometry.
Measured: Baseline, approximately 8 weeks, and postpartum days 7-14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purnawan Senoaji, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907094
- Sponsor's protocol ID
- 0028/KEPK-RSUPP/02/2024
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The availability of de-identified individual participant data for secondary research has not yet been determined. Any future data sharing will be subject to investigator and institutional approval, applicable ethics requirements, and appropriate safeguards for participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adjunctive Vitamin D3 Supplementation on Monocyte Subsets and Expression of Vitamin D Receptor and Interleukin-6 in Pregnant Women With Pulmonary Tuberculosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07907094
- Acronym / sponsor ID
- 0028/KEPK-RSUPP/02/2024
- Conditions
- Pulmonary Tuberculosis, Pregnancy
- Keywords
- Vitamin D3, Cholecalciferol, Pulmonary Tuberculosis, Pregnancy, Monocyte Subsets, Vitamin D Receptor, Interleukin-6, Innate Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated the effects of adjunctive vitamin D3 supplementation on circulating monocyte subsets and the expression of vitamin D receptor (VDR) and interleukin-6 (IL-6) in pregnant women with pulmonary tuberculosis.
A total of 32 pregnant women with pulmonary tuberculosis were allocated to receive either standard first-line anti-tuberculosis treatment alone or standard treatment plus oral vitamin D3 supplementation at a dose of 50,000 IU once weekly for eight weeks.
Serum 25-hydroxyvitamin D [25(OH)D] concentrations, monocyte subset distributions, and monocyte expression of VDR and IL-6 were assessed at baseline, approximately eight weeks after enrollment, and during the early postpartum period. Monocyte subsets were characterized by CD14 and CD16 expression using flow cytometry.
The study aimed to investigate whether adjunctive vitamin D3 supplementation modifies vitamin D status and monocyte-related immunological responses in pregnant women receiving treatment for pulmonary tuberculosis.
Detailed description
Tuberculosis during pregnancy represents an important clinical challenge because both Mycobacterium tuberculosis infection and pregnancy are associated with changes in maternal immune responses. Vitamin D is involved in the regulation of innate immunity, including monocyte and macrophage function. However, the effects of vitamin D3 supplementation on monocyte phenotypes and inflammatory marker expression in pregnant women with pulmonary tuberculosis remain insufficiently understood.
This study was designed as a two-arm randomized controlled trial conducted at Persahabatan General Hospital, Jakarta, Indonesia. Eligible pregnant women with pulmonary tuberculosis were consecutively recruited and allocated to either a control group receiving standard first-line anti-tuberculosis treatment or an intervention group receiving the same treatment supplemented with oral vitamin D3 at 50,000 IU once weekly for eight weeks.
Standard anti-tuberculosis treatment consisted of daily rifampicin, isoniazid, pyrazinamide, and ethambutol during the initial two months, followed by daily rifampicin and isoniazid for four months.
Blood samples were collected at baseline (T1), approximately eight weeks after baseline (T2; allowable window of 6-10 weeks), and during the early postpartum period (T3; postpartum days 7-14).
Serum 25(OH)D concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). Monocyte subsets were characterized using flow cytometry based on CD14 and CD16 expression and classified as classical, intermediate, or nonclassical monocytes. The relative distribution of classical and nonclassical monocytes was additionally evaluated using a logarithmically transformed classical-to-nonclassical monocyte ratio.
Intracellular IL-6 and VDR expression were assessed by flow cytometry, including the percentage of marker-positive monocytes and fluorescence intensity measurements.
Longitudinal analyses evaluated changes across the three assessment points using linear mixed models with treatment group, time, and their interaction as fixed effects. Additional analyses evaluated baseline-to-week-8 changes in monocyte markers, including exploratory analyses stratified by gestational age at enrollment.
The study was primarily designed to investigate laboratory and immunological responses rather than clinical tuberculosis treatment outcomes. Obstetric and neonatal outcomes were also documented descriptively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard TB Treatment | Active comparator | Drug: Standard First-Line Anti-Tuberculosis TreatmentParticipants received standard first-line anti-tuberculosis treatment consisting of daily rifampicin, isoniazid, pyrazinamide, and ethambutol for two months, followed by daily rifampicin and isoniazid for four months, without additional study-provided vitamin D3 supplementation. |
| Arm 2 - Vitamin D3 Plus Standard TB Treatment | Experimental | Dietary Supplement: Vitamin D3 (Cholecalciferol), Drug: Standard First-Line Anti-Tuberculosis TreatmentParticipants received standard first-line anti-tuberculosis treatment and adjunctive oral vitamin D3 supplementation at a dose of 50,000 IU once weekly for eight consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women at 28-32 weeks of gestation.
- Diagnosed with pulmonary tuberculosis or receiving first-line anti-tuberculosis treatment.
- Willing to participate in the study and provide written informed consent.
Key exclusion criteria (7 listed)
- Extrapulmonary tuberculosis.
- History of abortion, stillbirth, intrauterine fetal death, or previous placental disorders.
- History of autoimmune disease.
- History of cardiovascular disease or current treatment for a cardiovascular condition.
- History of kidney disease.
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 D3 (Cholecalciferol)Oral cholecalciferol (vitamin D3), 50,000 international units (IU) once weekly for eight weeks, administered as an adjunct to standard first-line anti-tuberculosis treatment. | Dietary supplement | Arm 2 - Vitamin D3 Plus Standard TB Treatment |
| Standard First-Line Anti-Tuberculosis TreatmentStandard first-line anti-tuberculosis treatment consisting of daily rifampicin, isoniazid, pyrazinamide, and ethambutol during the initial two months, followed by daily rifampicin and isoniazid for four months. | Drug | Arm 1 - Standard TB Treatment, Arm 2 - Vitamin D3 Plus Standard TB Treatment |
Primary outcome
Change in Serum 25-Hydroxyvitamin D Concentration From Baseline to Week 8 Copy
Time frame: Baseline and approximately 8 weeks after enrollment (6-10-week assessment window).
Change in serum 25-hydroxyvitamin D [25(OH)D] concentration, expressed in ng/mL, from baseline to approximately eight weeks after enrollment. Serum 25(OH)D concentrations were measured using an enzyme-linked immunosorbent assay (ELISA).
3 secondary outcomes
Change in Classical-to-Nonclassical Monocyte Ratio
Time frame: Baseline, approximately 8 weeks, and postpartum days 7-14.
Change in IL-6-Positive Monocyte Proportion
Time frame: Baseline, approximately 8 weeks, and postpartum days 7-14.
Change in VDR-Positive Monocyte Proportion
Time frame: Baseline, approximately 8 weeks, and postpartum days 7-14.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided. The availability of de-identified individual participant data for secondary research has not yet been determined. Any future data sharing will be subject to investigator and institutional approval, applicable ethics requirements, and appropriate safeguards for participant confidentiality.
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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 (Cholecalciferol) and Standard First-Line Anti-Tuberculosis Treatment in people with Pulmonary Tuberculosis and Pregnancy, run by Universitas Indonesia 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 3 inclusion and 7 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 30 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Serum 25-Hydroxyvitamin D Concentration From Baseline to Week 8 Copy (time frame: Baseline and approximately 8 weeks after enrollment (6-10-week assessment window).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.