Pulmonary TuberculosisNCT07899138
Effect of Vitamin D and Zinc Supplementation on Inflammatory Biomarkers in Pulmonary Tuberculosis Patients
A study testing Vitamin D (Cholecalciferol ) and Zinc (zinc sulphate) in people with Pulmonary Tuberculosis, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study evaluates the effect of combined Vitamin D and Zinc supplementation on inflammatory biomarkers in pulmonary tuberculosis (TB) patients during the intensive phase of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Vitamin D (Cholecalciferol ) and Zinc (zinc sulphate)
- 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
- 3 Jun 2026to 28 Aug 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Active pulmonary tuberculosis confirmed by positive acid-fast bacilli (AFB) sputum smear or positive molecular rapid test (GeneXpert/TCM), diagnosed by a pulmonologist.
- Currently undergoing the intensive phase of anti-tuberculosis therapy (ATT), with the duration of ATT treatment less than 14 days since initiation at the time of recruitment.
- Patients with vitamin D deficiency or insufficiency and zinc deficiency.
- Patient is willing to follow all study procedures for 8 weeks and signed the written informed consent.
- Patients who have not consumed vitamin D and/or zinc supplements within the last 30 days (wash-out period).
Who cannot join
- Patients with extra-pulmonary tuberculosis without lung involvement, or patients with suspected or confirmed MDR-TB/XDR-TB.
- Pregnant or breastfeeding women.
- Patients with diseases or conditions that alter vitamin D or calcium metabolism, such as hypercalcemia (total calcium >= 10.5 mg/dL), hyperparathyroidism, or a history of recurrent calcium nephrolitiasis.
- Severe liver failure or end-stage renal disease requiring chronic dialysis.
- Patients taking systemic immunosuppressive drugs (e.g., prednisone equivalent >10 mg/day for >= 14 days), active chemotherapy, or active unstable autoimmune disease.
- Patients with severe uncontrolled co-infections (e.g., sepsis, severe non-TB pneumonia) at the time of screening.
- Patients with known allergy or hypersensitivity to cholecalciferol or zinc preparations used in this study.
- Patients unable to follow the follow-up schedules or considered likely to drop out based on investigator's assessment.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Balai Besar Kesehatan Paru Masyarakat (BBKPM) Makassar
Makassar, South Sulawesi, 90143
About this study
Official title: Effect of Vitamin D And Zinc Supplementation on Inflammatory Biomarkers NLR, Interleukin-6 and Albumin In Pulmonary Tuberculosis Patients During The Intensive Phase
This study evaluates the effect of combined Vitamin D and Zinc supplementation on inflammatory biomarkers in pulmonary tuberculosis (TB) patients during the intensive phase of treatment. The main goal is to determine if this nutritional supplementation can help improve inflammatory levels by measuring biomarkers such as Neutrophil-to-Lymphocyte Ratio (NLR), Interleukin-6 (IL-6), and albumin.
Read the detailed description
Pulmonary tuberculosis remains a major global health issue, often leading to chronic inflammation and nutritional deficiencies. This clinical trial utilizes a true experimental, randomized parallel-group design to assess the therapeutic benefits of adding Vitamin D and Zinc to standard intensive-phase anti-tuberculosis therapy. Patients are evaluated over an 8-week intervention period to analyze changes in key inflammatory markers, including NLR, IL-6, and serum albumin levels.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Vitamin D (Cholecalciferol ), Zinc (zinc sulphate)
- Keywords
- Tuberculosis, Vitamin D, Zinc, Biomarkers
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )Dietary supplement
Vitamin D3 (Cholecalciferol) supplementation administered orally daily for 8 weeks, given in addition to standard anti-tuberculosis therapy. Participants in the High-Dose group receive 10,000 IU/day
Zinc (zinc sulphate)Dietary supplement
Zinc sulphate supplementation administered orally daily for 8 weeks. Participants in the High-Dose group receive an amount equivalent to 20 mg of elemental zinc/day.
Vitamin D (Cholecalciferol )Dietary supplement
Vitamin D3 (Cholecalciferol) supplementation administered orally daily for 8 weeks, given in addition to standard anti-tuberculosis therapy. Participants in the Low-Dose group receive 1,000 IU/day
Zinc (zinc sulphate)Dietary supplement
Zinc sulphate supplementation administered orally daily for 8 weeks. Participants in the Low-Dose group receive an amount equivalent to 10 mg of elemental zinc/day.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Vitamin D and Zinc | Experimental | Participants in this arm receive standard anti-tuberculosis therapy supplemented with a high-dose micronutrient regimen daily for 8 weeks, consisting of Vitamin D3 10,000 IU/day and elemental zinc 20 mg/day administered orally. Receives: Dietary Supplement: Vitamin D (Cholecalciferol ); Dietary Supplement: Zinc (zinc sulphate) |
| Low-Dose Vitamin D and Zinc | Experimental | Participants in this arm receive standard anti-tuberculosis therapy supplemented with a low-dose comparison micronutrient regimen daily for 8 weeks, consisting of Vitamin D3 1,000 IU/day and elemental zinc 10 mg/day administered orally. Receives: Dietary Supplement: Vitamin D (Cholecalciferol ); Dietary Supplement: Zinc (zinc sulphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Neutrophil-to-Lymphocyte Ratio (NLR)
NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count from peripheral blood samples to assess inflammatory status
Measured: Baseline and week 8
Change from baseline in Interleukin-6 (IL-6) levels
IL-6 levels are measured in pg/mL from serum samples using ELISA or standard laboratory assays to evaluate systemic inflammatory response.
Measured: Baseline and week 8
Change from baseline in serum albumin levels
Serum albumin levels are measured in g/dL from blood samples using standard automated laboratory chemistry analyzers to assess nutritional and inflammatory status.
Measured: Baseline and week 8
Secondary outcomes (1)
Change from baseline in malnutrition status based on GLIM criteria
Nutritional status and malnutrition severity are evaluated using the Global Leadership Initiative on Malnutrition (GLIM) criteria, incorporating phenotypic criteria (non-volitional weight loss, low body mass index, or reduced muscle mass) and etiologic criteria (reduced food intake/assimilation or disease burden/inflammation).
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start3 Jun 2026
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astri Nova, Hasanuddin University
- Investigators
- Aminuddin Aminuddin, MD, Ph.D, Sp.GK, Study chair, Department of Clinical Nutrition, Faculty of Medicine, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899138
- Sponsor's protocol ID
- 634/UN4.6.4.5.31/PP36/2026
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team to maintain patient confidentiality and privacy regarding their medical records, in accordance with the informed consent agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D And Zinc Supplementation on Inflammatory Biomarkers NLR, Interleukin-6 and Albumin In Pulmonary Tuberculosis Patients During The Intensive Phase
- ClinicalTrials.gov ID
- NCT07899138
- Acronym / sponsor ID
- 634/UN4.6.4.5.31/PP36/2026
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis, Vitamin D, Zinc, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 27 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 study evaluates the effect of combined Vitamin D and Zinc supplementation on inflammatory biomarkers in pulmonary tuberculosis (TB) patients during the intensive phase of treatment. The main goal is to determine if this nutritional supplementation can help improve inflammatory levels by measuring biomarkers such as Neutrophil-to-Lymphocyte Ratio (NLR), Interleukin-6 (IL-6), and albumin.
Detailed description
Pulmonary tuberculosis remains a major global health issue, often leading to chronic inflammation and nutritional deficiencies. This clinical trial utilizes a true experimental, randomized parallel-group design to assess the therapeutic benefits of adding Vitamin D and Zinc to standard intensive-phase anti-tuberculosis therapy. Patients are evaluated over an 8-week intervention period to analyze changes in key inflammatory markers, including NLR, IL-6, and serum albumin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Dose Vitamin D and Zinc | Experimental | Dietary Supplement: Vitamin D (Cholecalciferol ), Dietary Supplement: Zinc (zinc sulphate)Participants in this arm receive standard anti-tuberculosis therapy supplemented with a high-dose micronutrient regimen daily for 8 weeks, consisting of Vitamin D3 10,000 IU/day and elemental zinc 20 mg/day administered orally. |
| Low-Dose Vitamin D and Zinc | Experimental | Dietary Supplement: Vitamin D (Cholecalciferol ), Dietary Supplement: Zinc (zinc sulphate)Participants in this arm receive standard anti-tuberculosis therapy supplemented with a low-dose comparison micronutrient regimen daily for 8 weeks, consisting of Vitamin D3 1,000 IU/day and elemental zinc 10 mg/day administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged 18 years or older.
- Active pulmonary tuberculosis confirmed by positive acid-fast bacilli (AFB) sputum smear or positive molecular rapid test (GeneXpert/TCM), diagnosed by a pulmonologist.
- Currently undergoing the intensive phase of anti-tuberculosis therapy (ATT), with the duration of ATT treatment less than 14 days since initiation at the time of recruitment.
- Patients with vitamin D deficiency or insufficiency and zinc deficiency.
- Patient is willing to follow all study procedures for 8 weeks and signed the written informed consent.
Key exclusion criteria (8 listed)
- Patients with extra-pulmonary tuberculosis without lung involvement, or patients with suspected or confirmed MDR-TB/XDR-TB.
- Pregnant or breastfeeding women.
- Patients with diseases or conditions that alter vitamin D or calcium metabolism, such as hypercalcemia (total calcium >= 10.5 mg/dL), hyperparathyroidism, or a history of recurrent calcium nephrolitiasis.
- Severe liver failure or end-stage renal disease requiring chronic dialysis.
- Patients taking systemic immunosuppressive drugs (e.g., prednisone equivalent >10 mg/day for >= 14 days), active chemotherapy, or active unstable autoimmune 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 D (Cholecalciferol )Vitamin D3 (Cholecalciferol) supplementation administered orally daily for 8 weeks, given in addition to standard anti-tuberculosis therapy. Participants in the High-Dose group receive 10,000 IU/day | Dietary supplement | High-Dose Vitamin D and Zinc |
| Zinc (zinc sulphate)Zinc sulphate supplementation administered orally daily for 8 weeks. Participants in the High-Dose group receive an amount equivalent to 20 mg of elemental zinc/day. | Dietary supplement | High-Dose Vitamin D and Zinc |
| Vitamin D (Cholecalciferol )Vitamin D3 (Cholecalciferol) supplementation administered orally daily for 8 weeks, given in addition to standard anti-tuberculosis therapy. Participants in the Low-Dose group receive 1,000 IU/day | Dietary supplement | Low-Dose Vitamin D and Zinc |
| Zinc (zinc sulphate)Zinc sulphate supplementation administered orally daily for 8 weeks. Participants in the Low-Dose group receive an amount equivalent to 10 mg of elemental zinc/day. | Dietary supplement | Low-Dose Vitamin D and Zinc |
Primary outcome
Change from baseline in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Baseline and week 8
NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count from peripheral blood samples to assess inflammatory status
Change from baseline in Interleukin-6 (IL-6) levels
Time frame: Baseline and week 8
IL-6 levels are measured in pg/mL from serum samples using ELISA or standard laboratory assays to evaluate systemic inflammatory response.
Change from baseline in serum albumin levels
Time frame: Baseline and week 8
Serum albumin levels are measured in g/dL from blood samples using standard automated laboratory chemistry analyzers to assess nutritional and inflammatory status.
1 secondary outcome
Change from baseline in malnutrition status based on GLIM criteria
Time frame: Baseline and Week 8
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team to maintain patient confidentiality and privacy regarding their medical records, in accordance with the informed consent agreement.
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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.
Aminuddin Aminuddin, MD, Ph.D, Sp.GK study chair
Department of Clinical Nutrition, Faculty of Medicine, Hasanuddin University
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 D (Cholecalciferol ) and Zinc (zinc sulphate) in people with Pulmonary Tuberculosis, run by Hasanuddin University 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 6 inclusion and 8 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 27 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 from baseline in Neutrophil-to-Lymphocyte Ratio (NLR) (time frame: Baseline and week 8). The study lists 3 primary outcomes in all. 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 27 Oct 2026.