An interventional study of Vitamin D3 (Cholecalciferol) and Standard First-Line Anti-Tuberculosis Treatment in Pulmonary Tuberculosis and Pregnancy, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Universitas Indonesia · Not applicable, Interventional, and Basic science
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.
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.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 32 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Universitas Indonesia is the lead sponsor of 35 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Standard First-Line Anti-Tuberculosis Treatment
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.
Dietary Supplement: Vitamin D3 (Cholecalciferol) · Drug: Standard First-Line Anti-Tuberculosis Treatment
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 treatment consisting of daily rifampicin, isoniazid, pyrazinamide, and ethambutol during the initial two months, followed by daily rifampicin and isoniazid for four months.
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).
Time frame: Baseline and approximately 8 weeks after enrollment (6-10-week assessment window).
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, approximately 8 weeks, and postpartum days 7-14.
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Dec 2025, 12 months.
Of 42 non-industry interventional studies with no phase under Tuberculosis, Pulmonary, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 12 months is below that.
Counting every sponsor, half of 42 studies reached it within 17 months; a quarter within 11 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Universitas Indonesia