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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537170
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease
Tuberculosis Refeeding Syndrome Severe Malnutrition

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dietary Assessment and Prevalence of Refeeding Syndrome in High-risk TB Patients in Chhattisgarh, India
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018



Primary Outcome Measures :
  1. Inpatient caloric intake [ Time Frame: from date of admission to discharge, up to 100 weeks ]

Secondary Outcome Measures :
  1. Incidence of refeeding syndrome [ Time Frame: from date of admission to discharge, up to 100 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe tuberculosis patients admitted to the inpatient ward at Ganiyari hospital in Chhattisgarh, India.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to take enteral intake

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537170


Locations
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India
Jan Swasthya Sahyog
Ganiyari, Chhattisgarh, India
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03537170    
Other Study ID Numbers: 201710162
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Malnutrition
Refeeding Syndrome
Syndrome
Disease
Pathologic Processes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Nutrition Disorders