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

Introduction 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...

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Main Authors: Manjula Singh, Anurag Bhargava, Kannan Thiruvengadam, Madhavi Bhargava, Banurekha Velayutham, Basilea Watson, Rakesh Dayal, Rajeev Ranjan Pathak, Anindya Mitra, Kiran Rade, KS Sachdeva
Format: Article
Language:English
Published: BMJ Publishing Group 2021-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/5/e047210.full
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spelling doaj-bdda82aade6643e7a293b6030b46a6ef2021-10-01T21:00:06ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111510.1136/bmjopen-2020-047210The 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, IndiaManjula Singh0Anurag Bhargava1Kannan Thiruvengadam2Madhavi Bhargava3Banurekha Velayutham4Basilea Watson5Rakesh Dayal6Rajeev Ranjan Pathak7Anindya Mitra8Kiran Rade9KS Sachdeva10Division of ECD, Indian Council of Medical Research, New Delhi, Delhi, IndiaDepartment of Medicine, Yenepoya Medical College Hospital, Mangalore, IndiaNational Institute of Research in Tuberculosis, Chennai, IndiaCenter for Nutrition Studies, Yenepoya University, Mangalore, IndiaNational Institute of Research in Tuberculosis, Chennai, IndiaNational Institute of Research in Tuberculosis, Chennai, IndiaState TB Cell, Ranchi, IndiaWHO, Technical Support Network, Ranchi, IndiaState Tuberculosis Demonstration and Training Centre, Ranchi, IndiaWorld Health Organisation Country Office for India, New Delhi, IndiaNational Tuberculosis Elimination Programme, India Ministry of Health and Family Welfare, New Delhi, Delhi, IndiaIntroduction 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.Methods and analysis We shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 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 g 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.Ethics and dissemination The institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration number Clinical Trial Registry of India: CTRI/2019/08/020490.https://bmjopen.bmj.com/content/11/5/e047210.full
collection DOAJ
language English
format Article
sources DOAJ
author Manjula Singh
Anurag Bhargava
Kannan Thiruvengadam
Madhavi Bhargava
Banurekha Velayutham
Basilea Watson
Rakesh Dayal
Rajeev Ranjan Pathak
Anindya Mitra
Kiran Rade
KS Sachdeva
spellingShingle Manjula Singh
Anurag Bhargava
Kannan Thiruvengadam
Madhavi Bhargava
Banurekha Velayutham
Basilea Watson
Rakesh Dayal
Rajeev Ranjan Pathak
Anindya Mitra
Kiran Rade
KS Sachdeva
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
BMJ Open
author_facet Manjula Singh
Anurag Bhargava
Kannan Thiruvengadam
Madhavi Bhargava
Banurekha Velayutham
Basilea Watson
Rakesh Dayal
Rajeev Ranjan Pathak
Anindya Mitra
Kiran Rade
KS Sachdeva
author_sort Manjula Singh
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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publisher BMJ Publishing Group
series BMJ Open
issn 2044-6055
publishDate 2021-06-01
description Introduction 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.Methods and analysis We shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 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 g 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.Ethics and dissemination The institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration number Clinical Trial Registry of India: CTRI/2019/08/020490.
url https://bmjopen.bmj.com/content/11/5/e047210.full
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