Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis (ICTBSG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801606
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : February 10, 2016
University of Bergen
Information provided by (Responsible Party):
SK Kabra, All India Institute of Medical Sciences, New Delhi

Brief 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. 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 or disease Intervention/treatment Phase
Tuberculosis Drug: Zinc Drug: Micronutrient without zinc Drug: Micronutrient with zinc Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Study drug containing zinc alone
Zinc 20 mg daily
Drug: Zinc
Zinc 20 mg/day
Other Name: study drug
Experimental: Study drug Micronutrient without zinc
micronutrients (vitamin A, thiamine, riboflavin, vitamins B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, and copper) without zinc.
Drug: Micronutrient without zinc
Multimineral 2 RDA
Other Name: study drug
Experimental: Study drug Micronutrient with zinc
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).
Drug: Micronutrient with zinc
Multimineral 2 RDA and zinc 20 mg per day
Other Name: study drug
Placebo Comparator: Placebo
Placebo only
Drug: Placebo
Other Name: study drug

Primary Outcome Measures :
  1. Change in Z score for weight and improvement in X ray film [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Resolution of symptoms and interferon gamma activity at 2 and 6 months [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801606

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
Principal Investigator: Sushil Kr Kabra, MD All India Institute of Medical Sciences, New Delhi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SK Kabra, Dr, All India Institute of Medical Sciences, New Delhi Identifier: NCT00801606     History of Changes
Other Study ID Numbers: ICTBSG
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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