In a randomized trial in India, a nutritional intervention was associated with a substantial reduction in tuberculosis incidence among household contacts of patients.
In this open-label, cluster-randomized controlled trial, household members of 2800 adults with microbiologically confirmed pulmonary tuberculosis from 28 tuberculosis units were included. These units were randomized 1:1 to the control or intervention group. Although patients in both groups received food parcels (1200 kcal, 52 grams of protein per day, plus supplements) for 6 months, only housemates in the intervention group received these parcels (750 kcal, 23 grams of protein, plus supplements). All participants were actively followed until July 31, 2022 for the primary endpoint: the development of tuberculosis (all forms).
Between August 2019 and January 2021, 5328 household contacts in the intervention group and 4283 in the control group could be assessed for the primary outcome. 34% of them were malnourished. Over a period of 21,869 person-years, 218 household members (2.1%) were diagnosed with tuberculosis. 122 cases were in the control group (2.6%; 95% CI 2.2-3.1; incidence 1.27 per 100 person-years) and 96 cases in the intervention group (1.7%; 1.4-2. 1; 0.78 per 100 person-years). 152 of 218 cases (69.7%) had microbiologically confirmed pulmonary tuberculosis. The incidence of tuberculosis (all forms) in the intervention group had an adjusted IRR of 0.61 (95% CI 0.43-0.85; aHR 0.59, 0.42-0.83), with an even greater decrease in the incidence of microbiologically confirmed pulmonary tuberculosis (aIRR 0.52, 0.35-0.79; aHR 0.51, 0.34-0.78). This translated into a relative reduction in tuberculosis incidence from 39% (all forms) to 48% (microbiologically confirmed pulmonary tuberculosis) in the intervention group. It is estimated that 30 households (111 household contacts) would need to be provided with nutritional support to prevent 1 case of tuberculosis.
Bhargava A, Bhargava M, Meher A, et al. Nutritional supplementation to prevent tuberculosis incidence in household contacts of patients with pulmonary tuberculosis in India (RATIONS): a field-based, open-label, cluster-randomized, controlled trial. Lancet. 2023;402:627-40.