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| Name | Class |
|---|---|
| University of Bergen | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study drug containing zinc alone | Experimental | Zinc 20 mg daily |
|
| 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. |
|
| 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). |
|
| Placebo | Placebo Comparator | Placebo only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Drug | Zinc 20 mg/day |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Z score for weight and improvement in X ray film | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of symptoms and interferon gamma activity at 2 and 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sushil Kr Kabra, MD | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25332327 | Derived | 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. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D004341 | Drug Evaluation |
| D018977 | Micronutrients |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Micronutrient without zinc | Drug | Multimineral 2 RDA |
|
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| Micronutrient with zinc | Drug | Multimineral 2 RDA and zinc 20 mg per day |
|
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| Placebo | Drug | Placebo |
|
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008670 |
| Metals |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |