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To study the efficacy of Vitamin D as an adjunctive treatment along with Anti Tubercular Therapy on early sputum negativity in smear positive Pulmonary Tuberculosis

Randomized controlled trial to study the efficacy of Vitamin D as an adjunctive treatment along with ATT on early sputum conversion in smear positive Pulmonary Tuberculosis - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077220
Enrollment
80
Registered
2024-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: Therapeutic dose of Vitamin D along with ATT: Supplemented with oral doses of vitamin D3- 50,000 IU once a week for 8 weeks along with conventional Anti Tubercular Therapy. Control Inte

Sponsors

State Task force Punjab
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed microbiologically confirmed smear positive Pulmonary Tuberculosis with serum 25 hydroxy cholecalciferol levels less than 30 ng/ml

Exclusion criteria

Exclusion criteria: 1) Patient’s refusal 2) Pregnancy or lactation 3) Miliary TB 4) MDR TB 5) Old treated pulmonary TB 6) Hypersensitivity to Vitamin D supplements 7) A history of hypercalcemia, sarcoidosis, nephrolithiasis, hyperparathyroidism, seizures or cancer in the past. 8) Serum calcium above 10.5 mg/ml. 9) Current use of cytotoxic or immunosuppressive drug

Design outcomes

Primary

MeasureTime frame
1) To compare the rate of sputum conversion between vitamin D supplementation group and control groupTimepoint: 1 year

Secondary

MeasureTime frame
2) To evaluate the safety & tolerability profile of therapeutic dose of vitamin D in TB patientsTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Ayushi Singh

Punjab Institute of Medical Sciences

sandeepsoni079@yahoo.com9872818687

Outcome results

None listed

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