Cargando…
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 supplementatio...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141431/ https://www.ncbi.nlm.nih.gov/pubmed/34016663 http://dx.doi.org/10.1136/bmjopen-2020-047210 |
_version_ | 1783696362499473408 |
---|---|
author | Bhargava, Anurag Bhargava, Madhavi Velayutham, Banurekha Thiruvengadam, Kannan Watson, Basilea Kulkarni, Bharati Singh, Manjula Dayal, Rakesh Pathak, Rajeev Ranjan Mitra, Anindya Rade, Kiran Sachdeva, KS |
author_facet | Bhargava, Anurag Bhargava, Madhavi Velayutham, Banurekha Thiruvengadam, Kannan Watson, Basilea Kulkarni, Bharati Singh, Manjula Dayal, Rakesh Pathak, Rajeev Ranjan Mitra, Anindya Rade, Kiran Sachdeva, KS |
author_sort | Bhargava, Anurag |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-8141431 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-81414312021-06-07 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 Bhargava, Anurag Bhargava, Madhavi Velayutham, Banurekha Thiruvengadam, Kannan Watson, Basilea Kulkarni, Bharati Singh, Manjula Dayal, Rakesh Pathak, Rajeev Ranjan Mitra, Anindya Rade, Kiran Sachdeva, KS BMJ Open Infectious Diseases 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. BMJ Publishing Group 2021-05-20 /pmc/articles/PMC8141431/ /pubmed/34016663 http://dx.doi.org/10.1136/bmjopen-2020-047210 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Infectious Diseases Bhargava, Anurag Bhargava, Madhavi Velayutham, Banurekha Thiruvengadam, Kannan Watson, Basilea Kulkarni, Bharati Singh, Manjula Dayal, Rakesh Pathak, Rajeev Ranjan Mitra, Anindya Rade, Kiran Sachdeva, KS 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 | 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_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_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 |
topic | Infectious Diseases |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141431/ https://www.ncbi.nlm.nih.gov/pubmed/34016663 http://dx.doi.org/10.1136/bmjopen-2020-047210 |
work_keys_str_mv | AT bhargavaanurag therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT bhargavamadhavi therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT velayuthambanurekha therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT thiruvengadamkannan therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT watsonbasilea therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT kulkarnibharati therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT singhmanjula therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT dayalrakesh therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT pathakrajeevranjan therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT mitraanindya therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT radekiran therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT sachdevaks therationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighp AT bhargavaanurag rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT bhargavamadhavi rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT velayuthambanurekha rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT thiruvengadamkannan rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT watsonbasilea rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT kulkarnibharati rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT singhmanjula rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT dayalrakesh rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT pathakrajeevranjan rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT mitraanindya rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT radekiran rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev AT sachdevaks rationsreducingactivationoftuberculosisbyimprovementofnutritionalstatusstudyaclusterrandomisedtrialofnutritionalsupportfoodrationstoreducetbincidenceinhouseholdcontactsofpatientswithmicrobiologicallyconfirmedpulmonarytuberculosisincommunitieswithahighprev |