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Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis (ICTBSG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Bergen
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00801606
First received: December 2, 2008
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Tuberculosis
 Drug: Zinc
Drug: Multimineral
Drug: Multimineral and zinc
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Change in Z score for weight and improvement in X ray film [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resolution of symptoms and interferon gamma activity at 2 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: December 2008
Estimated Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zinc
Zinc 20 mg/day
Experimental: 2 Drug: Multimineral
Multimineral 2 RDA
Experimental: 3 Drug: Multimineral and zinc
Multimineral 2 RDA and zinc 20 mg per day
Placebo Comparator: 4 Drug: Placebo
Placebo

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:

  1. Effect of micronutrient supplements at 2 and 6 months on anthropometric parameters by comparing means of anthropometric parameters in different groups.
  2. 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.
  3. 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
  4. 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.
  5. Interferon gamma responses to M. tuberculosis antigens ESAT6 and CF10 by quantiferon assay at baseline, 2 months and 6 months of treatment
  6. To study effect of zinc supplementation on ocular toxicity in children receiving ethambutol by VER
  7. To document drug resistance (S, I, R, E) patterns among children with culture confirmed TB
  8. To document genotypic strain diversity among children with culture confirmed TB, also associations between strain type and disease severity and/or drug resistance
  9. To document the spectrum of mycobacterial species by culture in children clinically suspected of having pulmonary tuberculosis.
  Eligibility

Ages Eligible for Study:   6 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801606

Locations
India
Department of Pediatrics, All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
University of Bergen
Investigators
Principal Investigator: Sushil Kr Kabra, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Dr S K Kabra, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00801606     History of Changes
Other Study ID Numbers: ICTBSG
Study First Received: December 2, 2008
Last Updated: June 22, 2011
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Micronutrient
Childhood Tuberculosis

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

ClinicalTrials.gov processed this record on May 23, 2013