Objectives of the RATIONS trial and the outcome variables
| Objective | Outcome variables | Index case | HHC |
| Primary Objective | |||
| Effect of household nutritional supplementation in reducing TB incidence among HHC of patients with microbiologically confirmed PTB | Difference in number of incident cases of active TB (all forms) in the two arms detected by active case finding over a follow-up period of 2 years after diagnosis of index case | ✓ | |
| Secondary objectives | |||
| Effect of nutritional supplementation on anthropometric indicators over 6 months | Anthropometric indicators such as weight and BMI | ✓ | ✓ |
| Non-TB infectious morbidity and mortality in HHC in both the arms | Malaria, diarrhoea, lower respiratory tract infection, hospitalisation with fever of any cause or death with fever of any cause <15 days in duration | ✓ | |
| Adherence to anti-TB therapy | Proportion completing the therapy successfully | ✓ | |
| Mortality during treatment | Proportion of index cases who died during treatment | ✓ | |
| Adverse effects | Severe adverse effects with TB drugs | ✓ | |
| Recurrence of TB within 2 years after cure | Relapse rate of microbiologically confirmed TB | ✓ | |
| Performance status | Change in ECOG scale at 1 month, 2 months and 6 months compared with baseline | ✓ | |
| Dietary substudy | |||
| Evaluate the difference in dietary intake of calories and proteins | Calorie and protein intake at baseline, and end of treatment in intervention and control arms | ✓ | ✓ |
| Micronutrient substudy | |||
| Assess vitamins A and D (25-hydroxyvitamin D) levels | Level of vitamins A and D at baseline | ✓ | ✓ |
| Body composition substudy | |||
| Evaluation of body composition | Estimate fat-free mass, fat mass and other bioimpedance analysis parameters at baseline, and 6 months after treatment | ✓ | ✓ |
| Substudy on grip strength | |||
| Evaluate muscle strength using hand grip dynamometer | Grip strength at baseline and 6 months | ✓ | |
| Substudy of immune function | |||
| Evaluate cellular immunity in patients and HHC | Lymphocyte subsets (CD4, CD8, natural killer cells and B lymphocytes), fourth generation IGRA at baseline and end of treatment | ✓ | ✓ |
BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; HHC, household contacts; IGRA, Interferon Gamma Release Assay; PTB, pulmonary tuberculosis; RATIONS, Reducing Activation of Tuberculosis by Improvement of Nutritional Status.