| CTRI Number |
CTRI/2019/08/020490 [Registered on: 01/08/2019] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dry food rations to household/family] |
| Study Design |
Cluster Randomized Trial |
Public Title of Study
Modification(s)
|
Effect of food rations to prevent TB in household contacts of patients with TB |
|
Scientific Title of Study
|
The RATIONS (Reducing Activation of Tuberculosis by Improvement Of Nutritional Status) study:A cluster randomized trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with smear positive pulmonary tuberculosis in communities with a high prevalence of undernutrition |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Prof Anurag Bhargava |
| Address |
Center for Nutrition Studies, Yenepoya University Campus, Deralakatte, University Road, Mangalore
Dept of General Medicine, Yenepoya Medical College,
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8277408009 |
| Fax |
|
| Email |
anurag.bhargava@yenepoya.edu.in |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Prof Anurag Bhargava |
| Address |
Center for Nutrition Studies, Yenepoya University Campus, Deralakatte, University Road, Mangalore
Dept of General Medicine, Yenepoya Medical College,
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8277408009 |
| Fax |
|
| Email |
anurag.bhargava@yenepoya.edu.in |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Prof Anurag Bhargava |
| Address |
Center for Nutrition Studies, Yenepoya University Campus, Deralakatte, University Road, Mangalore
Dept of General Medicine, Yenepoya Medical College,
Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8277408009 |
| Fax |
|
| Email |
anurag.bhargava@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Anurag Bhargava |
| Address |
Center for Nutrition Studies
Yenepoya University Campus
University Road
Deralakatte
Mangalore |
| Type of Sponsor |
Other [Principle Investigator for the study.] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr VV Banurekha Scientist DMedical |
Department of Clinical Research
National Institute of Research in Tuberculosis
Indian Council of Medical Research
No.1, Mayor Sathiyamoorthy road,
Chetpet, Chennai-600031 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V V Banu Rekha |
Jharkhand |
C/O, State TB Cell
2nd Floor, Health Directorate,
State RCH Campus, Namkum,
Ranchi -834010, Jharkhand
Ranchi
|
08148024774
banurekha@nirt.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute for Research in Tuberculosis Institutional Ethics Committee (SIDCER Recognized Ethics Committee in the Asian and Western Pacific Region) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tuberculosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry food rations and 1 recommended daily allowance (RDA) of micronutrients as a supplement |
In the intervention arm, the patients with microbiologically confirmed tuberculosis, as well as their household contacts, shall receive dry food rations and 1 recommended daily allowance of micronutrients as a supplement.This will be in addition to the standard of care for patients and their contacts as per the guidelines of the Revised National Tuberculosis programme in India.The dry rations for the patients are aligned with the recommendations of the Guidance document: Nutritional care and support for patients with tuberculosis in India, while the dry rations to the family are based on the dietary guidelines for Indians framed by the National Institute of Nutrition. |
| Comparator Agent |
Dry food rations and 1 recommended daily allowance of micronutrients to patients alone. |
In the control arm,the patients with microbiologically confirmed tuberculosis will receive the dry food rations and micronutrient supplement, while the household contacts of patients with microbiologically confirmed pulmonary tuberculosis shall be on their usual diet. Both patients and contacts shall receive the standard of care for patients and contacts as per the guidelines of the Revised National Tuberculosis Control Programme of India. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are microbiologically positive pulmonary tuberculosis who have household contacts will be the index cases. Household contact is defined as a person of any age living in the same house as the index patient for one or more nights or for frequent or extended periods during the day with the index case for at least 3 months prior to the diagnosis. |
|
| ExclusionCriteria |
| Details |
Main exclusion criteria for household contacts: Current smear or CB-NAAT or LPA or culture-confirmed or clinically diagnosed pulmonary or extra-pulmonary TB or currently receiving anti-TB treatment |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis |
Any case of active TB diagnosed beyond 2 months after diagnosis of the index case up to follow-up period of 24 months after completion of therapy of index case |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
In all patients: treatment success rate, relapse, mortality during treatment and F/U and change in anthropometry, performance status.
In all contacts: change in anthropometric indices, select morbidities and mortality
In a sub-sample of patients and contacts: Calories and protein intakes, body composition, grip strength
Immune function assessed by CD4, CD8 counts and Interferon-gamma release assays in undernourished patients and contacts
|
Baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="2800"
Sample Size from India="2800" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Bhargava A, Bhargava M, Velayutham B, Thiruvengadam K, Watson B, Kulkarni B, Singh M, Dayal R, Pathak RR, Mitra A, Rade K, 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. BMJ Open. 2021 May 20;11(5):e047210. doi: 10.1136/bmjopen-2020-047210. |
Brief Summary
Modification(s)
|
The current END TB strategy needs substantial reductions in annual TB incidence for achievement of its targets. This requires development of new tools (more effective vaccines) and/or application of new interventions (addressing risk factors for TB incidence). Undernutrition impairs cell mediated immunity which protects against TB disease; It is the most widely prevalent risk factor and a major driver of the TB epidemic in India, accounting for 55% of the annual TB incidence. Social interventions which ensured adequate nutrition reduced TB incidence six-fold (RR= 0.16) in household contacts at the Papworth village settlement for TB affected households in the pre-chemotherapy era. Recent modelling studies indicate that nutritional interventions in the central and eastern Indian states with a high burden of TB and undernutrition have the potential of reducing TB incidence by 43-71%. Household contacts of patients with microbiologically confirmed pulmonary tuberculosis has a median incidence of TB which is 16-fold higher than in the general population. Current programmatic approaches to TB prevention in contacts in India are applied only for child contacts of drug-susceptible tuberculosis, and for those with co-existing HIV infection. In the current cluster randomized trial studies the effect of macronutrient nutritional support (raw food rations) on incidence of new TB cases in household contacts of patients with tuberculosis. In the control arm, only the patient will receive the food rations and other current standard of care. In the intervention arm, all the household contacts of the patients with tuberculosis will also receive the food rations during the treatment period. At the end of a total of 3 years, number of new incident cases of tuberculosis in contacts will be assessed in both the arms. |
