Nutritional support for adult patients with microbiologically confirmed pulmonary tuberculosis: outcomes in a programmatic cohort nested within the RATIONS trial in Jharkhand, India

Background Undernutrition is a common comorbidity of tuberculosis in countries with a high tuberculosis burden, such as India. RATIONS is a field-based, cluster-randomised controlled trial evaluating the effect of providing nutritional support to household contacts of adult patients with microbiologically confirmed pulmonary tuberculosis in Jharkhand, India, on tuberculosis incidence. The patient cohort in both groups of the trial was provided with nutritional support. In this study, we assessed the effects of nutritional support on tuberculosis mortality, treatment success, and other outcomes in the RATIONS patient cohort. Methods We enrolled patients (aged 18 years or older) with microbiologically confirmed pulmonary tuberculosis across 28 tuberculosis units. Patients received nutritional support in the form of food rations (1200 kcal and 52 g of protein per day) and micronutrient pills. Nutritional support was for 6 months for drug-susceptible tuberculosis and 12 months for multidrug-resistant tuberculosis; patients with drug-susceptible tuberculosis could receive an extension of up to 6 months if their BMI was less than 18.5 kg/m2 at the end of treatment. We recorded BMI, diabetes status, and modified Eastern Cooperative Oncology Group (ECOG) performance status at baseline. Clinical outcomes (treatment success, tuberculosis mortality, loss to follow-up, and change in performance status) and weight gain were recorded at 6 months. We assessed the predictors of tuberculosis mortality with Poisson and Cox regression using adjusted incidence rate ratios (IRRs) and adjusted hazard ratios (HRs). The RATIONS trial is registered with the Clinical Trials Registry of India (CTRI/2019/08/020490).Findings Between Aug 16, 2019, and Jan 31, 2021, 2800 patients (mean age 41.5 years [SD 14.5]; 1979 [70.7%] men and 821 [29.3%] women) were enrolled. At enrolment, 2291 (82.4%) patients were underweight (BMI <18.5 kg/m(2)), and 480 (17.3%) had a BMI of less than 14 kg/m(2). The mean weight and BMI were 42.6 kg (SD 7.8) and 16.4 kg/m2 (2.6) in men and 36.1 kg (7.3) and 16.2 kg/m(2) (2.9) in women. During the 6-month follow-up, treatment was successful in 2623 (93.7%) patients, 108 (3.9%) tuberculosis deaths occurred, 28 (1.0%) patients were lost to follow-up, and treatment failure was experienced by five (0.2%) patients. The median weight gain was 4.6 kg (IQR 2.8-6.8), but 1441 (54.8%) of 2630 patients remained underweight. At 2 months, 1444 (54.0%) of 2676 patients gained at least 5% of baseline weight. Baseline weight (adjusted IRR 0.95, 95% CI 0.90-0.99), BMI (0.88, 0.76-1.01), poor performance status (ECOG categories 3-4; 5.33, 2.90-9.79), diabetes (3.30, 1.65-6.72), and haemoglobin (0.85, 0.71-1.00) were predictors of tuberculosis mortality. A reduced hazard of death (adjusted HR 0.39, 95% CI 0.18-0.86) was associated with a 5% weight gain at 2 months.Interpretation In this study, nutritional support was provided to a cohort with a high prevalence of severe undernutrition. Weight gain, particularly in the first 2 months, was associated with a substantially decreased hazard of tuberculosis mortality. Nutritional support needs to be an integral component of patient-centred care to improve treatment outcomes in such settings. Lancet 11: Published August https://doi.org/10. 1016/ S2214 Department (Prof Department Medicine Department (Adarsh Medical India; Studies, be India M A of A of and (A Montreal, Council National in (A B B V State TB Tuberculosis Programme, (R Support India National Bangalore, (V Tuberculosis Programme, and India