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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Ministry of Science and Technology, India.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Science and Technology, India
ClinicalTrials.gov Identifier:
NCT00698386
First received: June 13, 2008
Last updated: September 14, 2009
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Pulmonary Tuberculosis
Dietary Supplement: Zinc supplement
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Oral Zinc Administration as an Adjunct Therapy in Category I Pulmonary Tuberculosis Along With Assessment of Immunological Parameters (Double-blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ministry of Science and Technology, India:

Primary Outcome Measures:
  • The time of sputum conversion as well as the early sputum conversion from the baseline between the two groups will be evaluated. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The cure rate will be evaluated as the primary parameter of efficacy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Recording of any clinical adverse reactions at anytime during the study for assessment of safety. [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • An additional secondary efficacy endpoint is the patient's and physician's global assessment of the clinical cure. [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Zinc 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.
    Dietary Supplement: Placebo
    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.
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 proteins, anthropometric indexes, and micronutrient status. Zinc plays role in protecting cells from the damaging effects of free radicals. Zinc supplementation was shown to prevent pulmonary pathology due to hypoxia-induced lung damage in rats. The role of zinc in faster sputum smear conversion has not yet been studied. However, there are reports which confirms, in vitro cellular killing of tubercle bacilli by macrophages after zinc supplementation.

We are investigating oral zinc supplement for its efficacy in TB patients in a "double-blind placebo-controlled randomized clinical trial" fashion. We are conducting this trial in Category-I pulmonary TB Patients (as per RNTCP, Ministry of Health and Family Welfare, Govt.of India), and are assessing the outcome in the form of clinical improvement, sputum conversion and immunological parameters. This is a multi-centric trial sponsored by the Department of Biotechnology, Ministry of Science and Technology, Govt. of India.

Supplements and placebo have been prepared by Cadila pharmaceutical Ltd., India, in the form of tablets. Each micronutrient tablet contains 50mg zinc (as zinc sulphate) in a lactose matrix. The placebo consisted of lactose alone. Supplement and placebo capsules were indistinguishable in appearance both externally and internally. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed sputum smear positive pulmonary TB cases.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698386

Contacts
Contact: Surendra K Sharma, MD,Ph.D 91-112-659-4415 surensk@gmail.com, sksharma@aiims.ac.in
Contact: Alladi Mohan, MD 91-877-228-7777 ext 2256 alladimohan@yahoo.com

Locations
India
All India Institute of Medcial Sciences- Recruiting
New Delhi, India, 110029
Contact: Surendra K Sharma, MD, Ph.D    26-594-415    surensk@gmail.com, sksharma@aiims.ac.in   
Contact: Alladi Mohan, MD    91-877-228-7777 ext 2256    alladimohan@yahoo.com   
Principal Investigator: Surendra K Sharma, MD, Ph.D         
Principal Investigator: Alladi Mohan, MD         
Sub-Investigator: Depender K Mitra, Ph.D         
Sponsors and Collaborators
Ministry of Science and Technology, India
Investigators
Principal Investigator: Surendra Kumar Sharma All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Surendra Kumar Sharma, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00698386     History of Changes
Other Study ID Numbers: DTPR7885/Med/141166/06
Study First Received: June 13, 2008
Last Updated: September 14, 2009
Health Authority: India: Ministry of Health

Keywords provided by Ministry of Science and Technology, India:
Micronutrient Zinc
Category I PTB
RNTCP
DOTS
Sputum smear conversion
Reduced relapse
Immunopathogenesis
Category-I

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014