An interventional study of Vitamin D (Cholecalciferol ) and Zinc (zinc sulphate) in Pulmonary Tuberculosis, sponsored by Hasanuddin University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment
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.
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.
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 →Hasanuddin University is the lead sponsor of 69 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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 planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Dietary Supplement: Vitamin D (Cholecalciferol ) · Dietary Supplement: Zinc (zinc sulphate)
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 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 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 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.
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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and week 8
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).
Time frame: Baseline and Week 8
Plan to share: 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.
No publications or documents are linked to this record.
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 drugs tested here: Vitamin D · Zinc Sulfate
Hasanuddin University