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NCT03537170 Clinical Trial

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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03537170
Other study ID # 201710162
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 23, 2017
Est. completion date February 14, 2018

Study information
Verified date May 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date February 14, 2018
Est. primary completion date February 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all adult inpatients admitted to the TB ward

- able to take enteral intake

Exclusion Criteria:

- unable to take enteral intake

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Jan Swasthya Sahyog Ganiyari Chhattisgarh

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inpatient caloric intake from date of admission to discharge, up to 100 weeks
Secondary Incidence of refeeding syndrome from date of admission to discharge, up to 100 weeks
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