Efficacy of Oral Zinc Administration as an Adjunct Therapy in New Pulmonary Tuberculosis (Category I) Patients

NCT00698386 | Unknown Phase 3 DMC

• 1 other identifier: DTPR7885/Med/141166/06
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 rapidly diminishes antibody- and cell-mediated immune responses in both humans and animals and renders the individual susceptible to a variety of pathogens. This micronutrient has also been found to be useful in the treatment of lung tuberculosis in limited number of patients. We are conducting this study in category-I patients (As per World Health Organization, Geneva classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see any change in the immunological parameters.

Conditions

Pulmonary Tuberculosis

Keywords

Micronutrient Zinc; Category I PTB; RNTCP; DOTS; Sputum smear conversion; Reduced relapse; Immunopathogenesis; Category-I

Outcome Measures

Primary Outcomes (4)

• The time of sputum conversion as well as the early sputum conversion from the baseline between the two groups will be evaluated.

  6 months

• The cure rate will be evaluated as the primary parameter of efficacy.

  6 months

• The relapse at an interval of 6,12,18 and 24 months after the completion of the therapy in patients of category-I pulmonary TB will be compared in both the groups.

  30 months

• Recording of any clinical adverse reactions at anytime during the study for assessment of safety.

  30 months

Secondary Outcomes (1)

• An additional secondary efficacy endpoint is the patient's and physician's global assessment of the clinical cure.

  30 months

Interventions

Zinc supplement DIETARY_SUPPLEMENT

Zinc miconutrient supplements have been prepared by Cadila pharmaceutical Ltd., India, in the form of capsules.Each micronutrient capsule contains 50mg zinc (as zinc sulphate) in a lactose matrix.In this clinical trial one tablet of zinc as oral supplement will be given everyday during the entire course in line with the directly observed treatment, short-course (DOTS) strategy recommended by the World Health Organization.

Placebo DIETARY_SUPPLEMENT

Placebo have been prepared by Cadila pharmaceutical Ltd., India, in the form of capsules.The placebo consisted of lactose alone. Supplement and placebo capsules were indistinguishable in appearance both externally and internally.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Newly diagnosed sputum smear positive pulmonary TB cases.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Science and Technology, India: lead

Study Sites (1)

All India Institute of Medcial Sciences-

New Delhi, New Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Surendra Kumar Sharma

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surendra K Sharma, MD,Ph.D

CONTACT

91-112-659-4415; surensk@gmail.com, sksharma@aiims.ac.in

Alladi Mohan, MD

CONTACT

91-877-228-7777; alladimohan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 15, 2009

Record last verified: 2008-06

Locations

IN (1)