Health Condition 1: J988- Other specified respiratory disorders Health Condition 2: A157- Primary respiratory tuberculosis
Conditions
Interventions
Intervention1: RUSF - ready to use supplementary food: Use of Ready to Use Supplementary food in malnourished children.
Group 1 (malnourished children with TB) and Group 3 children (malnourished chil
Sponsors
DBT
Eligibility
Inclusion criteria
Inclusion criteria: Age 12-60 months HIV-negative BCG vaccinated Moderate acute malnutrition (WHZ -2 to -3 or MUAC 115 â?? 125mm ± HAZ TB disease Latent TB infection
Exclusion criteria
Exclusion criteria: Inclusion criteria not met Severe acute malnutrition (WHZ Severe anaemia (Hb: Chronic infection (HIV, hepatitis B or C) Chronic disease (e.g. Crohnâ??s disease) Feeding problems (eg cerebral palsy) that prevent ingestion of RUSF Known nut allergy MDR TB disease and contacts of MDR TB adults
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IFNγ concentration in supernatant after overnight incubation of whole blood with ESAT-6, CFP-10 and TB antigensTimepoint: Baseline (0weeks), weeks 4, 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of children with detectable interferon-gamma, TNF-, IL-2 and IL-17 T-cell responses at weeks 0, 4, 12 and 24. Mean fluorescence intensity of T-cell interferon-gamma, TNF-, IL-2 and IL-17 at weeks 0, 4, 12 and 24. Mean concentration of IL-6, IL-12, TNF- and IL-10 at weeks 0, 4, 12 and 24. Mycobacterial growth inhibition at weeks 0, 4, 12 and 24. Anthropometry at weeks 4, 12 and 24. Progression to TB or severe acute malnutrition at weeks 4, 12 and 24. Recovery from TBTimepoint: Baseline, weeks 4,12 and 24 | — |
Countries
India
Contacts
Public ContactDr Aishwarya Venkataraman
National Institute for Research in Tuberculosis
Outcome results
None listed