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Study on whether giving Vitamin D helps speed up recovery in patients with Drug-Sensitive Tuberculosis treated at public hospital in Western India.

Effect of vitamin D supplementation on tuberculosis treatment outcome among Newly Registered Drug-Sensitive Tuberculosis (DSTB) patients at public health facilities of Western India. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/089992
Enrollment
1000
Registered
2025-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Vitamin D3 (Cholecalciferol) supplementation in addition to standard anti-tuberculosis therapy (DOTS) as per NTEP guidelines.: Vitamin D3- Dose- 60,000 IU. Frequency- once a week. Rout

Sponsors

Dr Dularikunwarba Zala
Lead Sponsor
Dr Kedar Mehta
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed drug-sensitive tuberculosis (DSTB) patients, pulmonary or extra-pulmonary, aged 18 years and above, willing to participate and provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they have drug-resistant tuberculosis (MDR/XDR), are HIV-positive, have chronic kidney disease evidenced by elevated serum creatinine levels or have significant chronic liver disease. Patients will also be excluded if they have known hypercalcemia, a history of vitamin D toxicity, granulomatous diseases such as sarcoidosis, primary hyperparathyroidism, or malignancies associated with hypercalcemia (e.g., lymphoma, multiple myeloma). Individuals currently taking vitamin D supplements, those on digitalis (digoxin) therapy, pregnant or lactating women, and patients with a known hypersensitivity to vitamin D preparations will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Higher sputum smear conversion rates and improved overall treatment success rate. Timepoint: Sputum smear microscopy will be performed at- 2 months and at 6 months, to assess conversion from smear-positive to smear-negative status.

Secondary

MeasureTime frame
Greater weight gain, improvement in other clinical symptoms, monitoring & recording of any adverse events.Timepoint: Outcome parameters will be assessed at baseline prior to treatment initiation, at 4 weeks, 8 weeks & monthly thereafter at 12, 16, 20 & 24 weeks, including at the point of treatment completion at 6 months.

Countries

India

Contacts

Public ContactDr Kedar Mehta

GMERS medical college, Gotri.

kedar_mehta20@yahoo.co.in9879036835

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026