Dietary Assessment and Prevalence of Refeeding Syndrome in High-risk TB Patients in Chhattisgarh, India

May 23, 2018 updated by: Washington University School of Medicine
Severe tuberculosis (TB) leads to wasting and anorexia, increasing risk of the refeeding syndrome (RFS) as defined by current criteria. TB patients have high metabolic rates and require a high calorie diet, with nutritional supplementation programs improving outcomes. BMI inversely correlates with mortality in these patients. Risk of RFS, a life-threatening syndrome associated with initiation of feeding after a period of low intake, has not been studied in this population and it is not known whether severely malnourished TB patients benefit from lower caloric intake. This study aimed to examine the prevalence of RFS in TB inpatients in rural India and correlate this with baseline and inpatient caloric intake.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chhattisgarh
      • Ganiyari, Chhattisgarh, India
        • Jan Swasthya Sahyog

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe tuberculosis patients admitted to the inpatient ward at Ganiyari hospital in Chhattisgarh, India.

Description

Inclusion Criteria:

  • all adult inpatients admitted to the TB ward
  • able to take enteral intake

Exclusion Criteria:

  • unable to take enteral intake

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inpatient caloric intake
Time Frame: from date of admission to discharge, up to 100 weeks
from date of admission to discharge, up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of refeeding syndrome
Time Frame: from date of admission to discharge, up to 100 weeks
from date of admission to discharge, up to 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2017

Primary Completion (Actual)

February 14, 2018

Study Completion (Actual)

February 14, 2018

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201710162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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