Pulmonary TuberculosisPhase 3NCT00698386
Efficacy of Oral Zinc Administration as an Adjunct Therapy in New Pulmonary Tuberculosis (Category I) Patients
A Phase 3 study testing Zinc supplement in people with Pulmonary Tuberculosis, run by Ministry of Science and Technology, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Zinc supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2008to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed sputum smear positive pulmonary TB cases.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medcial Sciences-
New Delhi, New Delhi, 110029
Surendra K Sharma, MD, Ph.D, 26-594-415, surensk@gmail.com, sksharma@aiims.ac.in
Alladi Mohan, MD, 91-877-228-7777 ext. 2256, alladimohan@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Zinc supplement, Placebo
- Keywords
- Micronutrient Zinc, Category I PTB, RNTCP, DOTS, Sputum smear conversion, Reduced relapse, Immunopathogenesis, Category-I
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc supplementDietary 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.
PlaceboDietary 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of sputum conversion as well as the early sputum conversion from the baseline between the two groups will be evaluated.
Measured: 6 months
The cure rate will be evaluated as the primary parameter of efficacy.
Measured: 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.
Measured: 30 months
Recording of any clinical adverse reactions at anytime during the study for assessment of safety.
Measured: 30 months
Secondary outcomes (1)
An additional secondary efficacy endpoint is the patient's and physician's global assessment of the clinical cure.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, India
- Sponsor type
- Other government
- Investigators
- Surendra Kumar Sharma, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698386
- Sponsor's protocol ID
- DTPR7885/Med/141166/06
- Status last verified
- Jun 2008
- First submitted
- 13 Jun 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00698386
- Acronym / sponsor ID
- DTPR7885/Med/141166/06
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Micronutrient Zinc, Category I PTB, RNTCP, DOTS, Sputum smear conversion, Reduced relapse, Immunopathogenesis, Category-I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology, IndiaOther government
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Newly diagnosed sputum smear positive pulmonary TB cases.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc supplementZinc 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 | – |
| PlaceboPlacebo 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. | Dietary supplement | – |
Primary outcome
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
The cure rate will be evaluated as the primary parameter of efficacy.
Time frame: 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.
Time frame: 30 months
Recording of any clinical adverse reactions at anytime during the study for assessment of safety.
Time frame: 30 months
1 secondary outcome
An additional secondary efficacy endpoint is the patient's and physician's global assessment of the clinical cure.
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surendra Kumar Sharma principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zinc supplement in people with Pulmonary Tuberculosis, run by Ministry of Science and Technology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surendra K Sharma, MD,Ph.D (91-112-659-4415, surensk@gmail.com, sksharma@aiims.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.