Pulmonary Tuberculosis
Conditions
Keywords
Tuberculosis, Vitamin D, Zinc, Biomarkers
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTVitamin 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_SUPPLEMENTZinc (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.
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged 18 years or older. 2. Active pulmonary tuberculosis confirmed by positive acid-fast bacilli (AFB) sputum smear or positive molecular rapid test (GeneXpert/TCM), diagnosed by a pulmonologist. 3. 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. 4. Patients with vitamin D deficiency or insufficiency and zinc deficiency. 5. Patient is willing to follow all study procedures for 8 weeks and signed the written informed consent. 6. Patients who have not consumed vitamin D and/or zinc supplements within the last 30 days (wash-out period).
Exclusion criteria
1. Patients with extra-pulmonary tuberculosis without lung involvement, or patients with suspected or confirmed MDR-TB/XDR-TB. 2. Pregnant or breastfeeding women. 3. 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. 4. Severe liver failure or end-stage renal disease requiring chronic dialysis. 5. Patients taking systemic immunosuppressive drugs (e.g., prednisone equivalent \>10 mg/day for \>= 14 days), active chemotherapy, or active unstable autoimmune disease. 6. Patients with severe uncontrolled co-infections (e.g., sepsis, severe non-TB pneumonia) at the time of screening. 7. Patients with known allergy or hypersensitivity to cholecalciferol or zinc preparations used in this study. 8. Patients unable to follow the follow-up schedules or considered likely to drop out based on investigator's assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Neutrophil-to-Lymphocyte Ratio (NLR) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in malnutrition status based on GLIM criteria | Baseline and Week 8 | 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). |
Countries
Indonesia
Contacts
STUDY_CHAIRAminuddin Aminuddin, MD, Ph.D, Sp.GK
Department of Clinical Nutrition, Faculty of Medicine, Hasanuddin University
Outcome results
None listed