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CompletedNCT03537170Updated May 25, 2018

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

An observational study in Tuberculosis, Refeeding Syndrome and Severe Malnutrition, sponsored by Washington University School of Medicine. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-25.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Tuberculosis
  • Refeeding Syndrome
  • Severe Malnutrition
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 31 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • unable to take enteral intake
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Inpatient caloric intake

    Time frame: from date of admission to discharge, up to 100 weeks

Secondary outcomes

  1. Incidence of refeeding syndrome

    Time frame: from date of admission to discharge, up to 100 weeks

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Study locations

1 site
  • Jan Swasthya Sahyog
    Ganiyari, Chhattisgarh, India
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03537170
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
May 25, 2018
Start date
Nov 23, 2017
Primary completion
Feb 14, 2018
Completion
Feb 14, 2018
Last update
May 25, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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