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Effect of food rations to prevent TB in household contacts of patients with TB

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 - RATIONS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020490
Enrollment
2800
Registered
2019-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A15-A19- Tuberculosis

Interventions

Intervention1: 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

Sponsors

Dr Anurag Bhargava
Lead Sponsor
Dr VV Banurekha Scientist DMedical
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosisTimepoint: 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

MeasureTime frame
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 Timepoint: Baseline and end of treatment

Countries

India

Contacts

Public ContactProf Anurag Bhargava

Yenepoya (Deemed to be Univeristy)

anurag.bhargava@yenepoya.edu.in8277408009

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026