Table 4

Schedule of enrolment, assessments at baseline and follow-up in the RATIONS trial

InvestigationsBaselineM1M2M3M4M5M6M7M8M9M10M11M12M15M18M21M24
In index cases                 
1Informed consentX                
2Demography, socio-economic status, comorbidities, household characteristics and access to PDSX                
3Clinical evaluationXXXXXXXXXXXXXXXXX
4Anthropometry (height, weight and MUAC) and SpO2 pedal oedemaXXXXXXXXXXXXXXXXX
5*Laboratory evaluation RBS, HIV and HbX                
6Compliance to nutritional supplement in new cases (12 months in MDR-TB)XXXXXXXXXXXXX    
7Performance status (modified ECOG Scale)XXX   XXXXXXX    
8*CB-NAATX      (in case of symptoms of recurrent disease)
9*CXRX     X          
In subsample of index cases                 
1Dietary recall of calories and protein intakeX     X          
2Body composition (by BIA)X     X          
3Micronutrient estimation (vitamins A and D)X                
4Hand grip strengthX     X          
5Immunological tests (fourth-generation IGRA, lymphocyte subsets)X     X          
In household contacts                 
1Informed consentX                
2Baseline demography, socioeconomic status, comorbid conditions, household characteristics and access to PDSX                
3Symptom screenXXXXXXX  X  XXXXX
4.Clinical evaluation if symptomaticXIn case of symptoms of active TB
5Anthropometry (height, weight and MUAC)XXXXXXX  X  XXXXX
6Compliance to nutritional supplement (intervention arm) (12 months in MDR-TB)XXXXXXX          
7.Review of non-TB infectious illnesses†XXXXXXXXXXXXXXXXX
8Sputum smear, CB-NAAT In case of symptoms of active TB
9CXR‡X In case of symptoms of active TB
In subsample of household contacts                 
1.Dietary recall of calories, protein intakeX     X          
2Body composition (by BIA)X     X          
3Micronutrient estimation (vitamins A and D)X                
4Immunological tests (fourth-generation IGRA and lymphocyte subsets)X     X          

  • *Through public health system.

  • †Respiratory infections, diarrhoea, hospitalisation with fever of any cause and death due to fever <15 days duration.

  • ‡For children under 5 years of age, symptomatic contacts.

  • BIA, Bioimpedance analysis; CB-NAAT, cartridge-based nucleic acid amplification test; CXR, chest X-ray; ECOG, Eastern Cooperative Oncology Group; Hb, haemoglobin; HIV, HIV immunodeficiency virus; IGRA, Interferon Gamma Release Assay; MDR-TB, multidrug resistant tuberculosis; MUAC, mid upper arm circumference; MUAC, mid-upper arm circumference; PDS, public distribution system; RATIONS, Reducing Activation of Tuberculosis by Improvement of Nutritional Status; RBS, random blood sugar; SpO2, oxygen saturation; TB, tuberculosis.