{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T08:58:16Z","timestamp":1789721896224,"version":"4.0.1"},"reference-count":39,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T00:00:00Z","timestamp":1621468800000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Tuberculosis Research Consortium, Indian Council of Medical Research","award":["5\/8\/5\/57\/TB Consortium\/Call India Project\/2017\/ECD"],"award-info":[{"award-number":["5\/8\/5\/57\/TB Consortium\/Call India Project\/2017\/ECD"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,5,5]]},"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>India has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11\u2009200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins\/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23\u2009g proteins\/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289\/NIRT-IEC\/2018). The results will be disseminated in publications and presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>Clinical Trial Registry of India: CTRI\/2019\/08\/020490.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-047210","type":"journal-article","created":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T11:22:00Z","timestamp":1621509720000},"page":"e047210","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7187-8759","authenticated-orcid":false,"given":"Anurag","family":"Bhargava","sequence":"first","affiliation":[{"name":"Department of Medicine, Yenepoya Medical College Hospital, Mangalore, India"},{"name":"Center for Nutrition Studies, Yenepoya University, Mangalore, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7480-566X","authenticated-orcid":false,"given":"Madhavi","family":"Bhargava","sequence":"additional","affiliation":[{"name":"Center for Nutrition Studies, Yenepoya University, Mangalore, India"},{"name":"Department of Community Medicine, Yenepoya Medical College Hospital, Mangalore, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Banurekha","family":"Velayutham","sequence":"additional","affiliation":[{"name":"National Institute of Research in Tuberculosis, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kannan","family":"Thiruvengadam","sequence":"additional","affiliation":[{"name":"National Institute of Research in Tuberculosis, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Basilea","family":"Watson","sequence":"additional","affiliation":[{"name":"National Institute of Research in Tuberculosis, Chennai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0636-318X","authenticated-orcid":false,"given":"Bharati","family":"Kulkarni","sequence":"additional","affiliation":[{"name":"National Institute of Nutrition, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8656-3768","authenticated-orcid":false,"given":"Manjula","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of ECD, Indian Council of Medical Research, New Delhi, Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakesh","family":"Dayal","sequence":"additional","affiliation":[{"name":"State TB Cell, Ranchi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajeev Ranjan","family":"Pathak","sequence":"additional","affiliation":[{"name":"WHO, Technical Support Network, Ranchi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anindya","family":"Mitra","sequence":"additional","affiliation":[{"name":"State Tuberculosis Demonstration and Training Centre, Ranchi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiran","family":"Rade","sequence":"additional","affiliation":[{"name":"World Health Organisation Country Office for India, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"KS","family":"Sachdeva","sequence":"additional","affiliation":[{"name":"National Tuberculosis Elimination Programme, India Ministry of Health and Family Welfare, New Delhi, Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,5,20]]},"reference":[{"key":"2025120521421935000_11.5.e047210.1","unstructured":"World Health Organization . 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