TuberculosisPhase 3ICTBSGNCT00801606
Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis
A Phase 3 study testing Zinc, Micronutrient without zinc and Micronutrient with zinc in people with Tuberculosis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Zinc, Micronutrient without zinc and Micronutrient with zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 403 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Jun 2012
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years
Who cannot join
- Weight for height < 70 % of NCHS median (reason: zinc as per guidelines is given as standard point of care to all severely malnourished children)
- Bilateral pedal oedema
- Known HIV + ve
- Place of residence outside Delhi (including physicians discretion)
- History of previous ATT treatment or INH prophylaxis for more than 48 hours prior to enrollment
- Signs of upper airway obstruction, or an arterial oxygen saturation less than 92% in room air
Show all 11Show fewer
- Signs of renal, hepatic, or cvs disease
- Unable to attend follow up session for reading of Mantoux tests
- Documented intake of zinc continuously for > 2 weeks in the preceding 4 weeks at enrollment
- CNS, osteo-articular, pericardial, renal TB
- History of contact with a documented case of drug resistant TB
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Pediatrics, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients
A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.
Read the detailed description
We plan to do a randomized controlled trial to study impact of multimineral supplement with antituberculosis drugs in freshly diagnosed pulmonary tuberculosis in children. Plan to enrol 400 children at two sites in Delhi. The diagnosis and treatment of pulmonary tuberculosis will be based on recommendations of Revised National Tuberculosis Control Program (RNTCP). The outcome will be measured in form of weight gain and improvement in x ray film of chest. The secondary outcome variables will be as follows:
- Effect of micronutrient supplements at 2 and 6 months on anthropometric parameters by comparing means of anthropometric parameters in different groups.
- Improvement in radiological findings at 2 months: Comparing the proportion of children showing clearance of X ray films at baseline and 6 months by two paediatricians independently using same protocol.
- Resolution of symptoms at 2 and 6 months: By comparing proportion of patients having resolution of presenting symptoms (fever, cough, appetite improvement) as reported by parents
- Proportion of children requiring extension of intensive phase of therapy: Comparing proportion of children in different groups requiring extension of intensive phase of therapy at 2 months due to the treating physician's decision.
- Interferon gamma responses to M. tuberculosis antigens ESAT6 and CF10 by quantiferon assay at baseline, 2 months and 6 months of treatment
- To study effect of zinc supplementation on ocular toxicity in children receiving ethambutol by VER
- To document drug resistance (S, I, R, E) patterns among children with culture confirmed TB
- To document genotypic strain diversity among children with culture confirmed TB, also associations between strain type and disease severity and/or drug resistance
- To document the spectrum of mycobacterial species by culture in children clinically suspected of having pulmonary tuberculosis.
- Conditions
- Tuberculosis
- Being tested
- Zinc, Micronutrient without zinc, Micronutrient with zinc, Placebo
- Keywords
- Micronutrient, Childhood Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDrug
Also called study drug
Zinc 20 mg/day
Micronutrient without zincDrug
Also called study drug
Multimineral 2 RDA
Micronutrient with zincDrug
Also called study drug
Multimineral 2 RDA and zinc 20 mg per day
PlaceboDrug
Also called study drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study drug containing zinc alone | Experimental | Zinc 20 mg daily Receives: Drug: Zinc |
| Study drug Micronutrient without zinc | Experimental | micronutrients (vitamin A, thiamine, riboflavin, vitamins B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, and copper) without zinc. Receives: Drug: Micronutrient without zinc |
| Study drug Micronutrient with zinc | Experimental | micronutrients in combination with zinc (vitamin A, thiamine, riboflavin, vitamin B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, copper, and 20 mg elemental zinc). Receives: Drug: Micronutrient with zinc |
| Placebo | Placebo comparator | Placebo only Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Z score for weight and improvement in X ray film
Measured: 6 months
Secondary outcomes (1)
Resolution of symptoms and interferon gamma activity at 2 and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Principal investigator, SK Kabra, All India Institute of Medical Sciences
- Investigators
- Sushil Kr Kabra, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801606
- Sponsor's protocol ID
- ICTBSG
- Acronym
- ICTBSG
- Status last verified
- Feb 2016
- First submitted
- 2 Dec 2008
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lodha R, Mukherjee A, Singh V, Singh S, Friis H, Faurholt-Jepsen D, Bhatnagar S, Saini S, Kabra SK, Grewal HM; Delhi Pediatric TB Study Group. Effect of micronutrient supplementation on treatment outcomes in children with intrathoracic tuberculosis: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1287-97. doi: 10.3945/ajcn.113.082255. Epub 2014 Sep 10.
PubMed 25332327
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT00801606
- Acronym / sponsor ID
- ICTBSG / ICTBSG
- Conditions
- Tuberculosis
- Keywords
- Micronutrient, Childhood Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Dec 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.
A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.
Detailed description
We plan to do a randomized controlled trial to study impact of multimineral supplement with antituberculosis drugs in freshly diagnosed pulmonary tuberculosis in children. Plan to enrol 400 children at two sites in Delhi. The diagnosis and treatment of pulmonary tuberculosis will be based on recommendations of Revised National Tuberculosis Control Program (RNTCP). The outcome will be measured in form of weight gain and improvement in x ray film of chest. The secondary outcome variables will be as follows:
- Effect of micronutrient supplements at 2 and 6 months on anthropometric parameters by comparing means of anthropometric parameters in different groups.
- Improvement in radiological findings at 2 months: Comparing the proportion of children showing clearance of X ray films at baseline and 6 months by two paediatricians independently using same protocol.
- Resolution of symptoms at 2 and 6 months: By comparing proportion of patients having resolution of presenting symptoms (fever, cough, appetite improvement) as reported by parents
- Proportion of children requiring extension of intensive phase of therapy: Comparing proportion of children in different groups requiring extension of intensive phase of therapy at 2 months due to the treating physician's decision.
- Interferon gamma responses to M. tuberculosis antigens ESAT6 and CF10 by quantiferon assay at baseline, 2 months and 6 months of treatment
- To study effect of zinc supplementation on ocular toxicity in children receiving ethambutol by VER
- To document drug resistance (S, I, R, E) patterns among children with culture confirmed TB
- To document genotypic strain diversity among children with culture confirmed TB, also associations between strain type and disease severity and/or drug resistance
- To document the spectrum of mycobacterial species by culture in children clinically suspected of having pulmonary tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study drug containing zinc alone | Experimental | Drug: ZincZinc 20 mg daily |
| Study drug Micronutrient without zinc | Experimental | Drug: Micronutrient without zincmicronutrients (vitamin A, thiamine, riboflavin, vitamins B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, and copper) without zinc. |
| Study drug Micronutrient with zinc | Experimental | Drug: Micronutrient with zincmicronutrients in combination with zinc (vitamin A, thiamine, riboflavin, vitamin B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, copper, and 20 mg elemental zinc). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo only |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years
Key exclusion criteria (11 listed)
- Weight for height < 70 % of NCHS median (reason: zinc as per guidelines is given as standard point of care to all severely malnourished children)
- Bilateral pedal oedema
- Known HIV + ve
- Place of residence outside Delhi (including physicians discretion)
- History of previous ATT treatment or INH prophylaxis for more than 48 hours prior to enrollment
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 |
|---|---|---|
| ZincAlso: study drugZinc 20 mg/day | Drug | Study drug containing zinc alone |
| Micronutrient without zincAlso: study drugMultimineral 2 RDA | Drug | Study drug Micronutrient without zinc |
| Micronutrient with zincAlso: study drugMultimineral 2 RDA and zinc 20 mg per day | Drug | Study drug Micronutrient with zinc |
| PlaceboAlso: study drugPlacebo | Drug | Placebo |
Primary outcome
Change in Z score for weight and improvement in X ray film
Time frame: 6 months
1 secondary outcome
Resolution of symptoms and interferon gamma activity at 2 and 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Derived from this study: PubMed 25332327Lodha R, Mukherjee A, Singh V, Singh S, Friis H, Faurholt-Jepsen D, Bhatnagar S, Saini S, Kabra SK, Grewal HM; Delhi Pediatric TB Study Group. Effect of micronutrient supplementation on treatment outcomes in children with intrathoracic tuberculosis: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1287-97. doi: 10.3945/ajcn.113.082255. Epub 2014 Sep 10.
- Individual participant dataSharing planned: No
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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.
Sushil Kr Kabra, MD 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, Micronutrient without zinc and Micronutrient with zinc in people with Tuberculosis, run by All India Institute of Medical Sciences 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 11 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: finished, as of the sponsor's last update on 10 Feb 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Z score for weight and improvement in X ray film (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801606, which also lists 1 linked publication.
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 10 Feb 2016.