Status:
UNKNOWN
Efficacy of Oral Zinc Administration as an Adjunct Therapy in New Pulmonary Tuberculosis (Category I) Patients
Lead Sponsor:
Ministry of Science and Technology, India
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the efficacy of oral Zinc administration in new smear positive pulmonary tuberculosis patients. Evidence is available suggesting that zinc deficiency ...
Detailed Description
Malnutrition is commonly observed in patients with pulmonary tuberculosis. There are reports claiming patients with active pulmonary tuberculosis are malnourished as indicated by diminished visceral p...
Eligibility Criteria
Inclusion
- Newly diagnosed sputum smear positive pulmonary TB cases.
Exclusion
- Hypersensitivity to Category I anti-TB drugs.
- Category II pulmonary TB and multi-drug resistant TB (MDR-TB). patients.
- Presence of secondary immunodeficiency states: HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids Hepatitis B and C positivity.
- Patients with extrapulmonary TB and/or patients requiring surgical intervention.
- Currently receiving cytotoxic therapy, or have received it within the last 3 months.
- Pregnancy and lactation.
- Patients with a known seizure disorder.
- Patients with known symptomatic cardiac diseases, such as arrhythmias or coronary artery disease.
- Patients with abnormal renal function (serum creatinine more than 2 mg/dl or more than 2+ proteinuria or both).
- Patients with abnormal hepatic functions (serum bilirubin \> 1.5 mg/dl; AST, ALT, SAP more than 1.5 times of upper limit of normal; PT = 1.3 times of control).
- Patients with hematological abnormalities (WBC lesser than or equal to3000/ cubic mm; platelets less than or equal to 100,000/cubic mm).
- Seriously ill and moribund patients with complications: low lung reserve, marked tachypnoea, chronic corpulmonale, congestive cardiac failure, BMI\<15, severe hypoalbuminemia.
- Patients unable to survive for less than 6 months.
- Patients unable to comply with the treatment regimen.
- Patients with history of alcohol or drug abuse.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00698386
Start Date
February 1 2008
End Date
September 1 2009
Last Update
September 15 2009
Active Locations (1)
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1
All India Institute of Medcial Sciences-
New Delhi, New Delhi, India, 110029