NCT03537170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 11, 2018

Last Update Submit

May 23, 2018

Conditions

TuberculosisRefeeding SyndromeSevere Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Inpatient caloric intake

    from date of admission to discharge, up to 100 weeks

Secondary Outcomes (1)

  • Incidence of refeeding syndrome

    from date of admission to discharge, up to 100 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • unable to take enteral intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jan Swasthya Sahyog

Ganiyari, Chhattisgarh, India

Location

MeSH Terms

Conditions

TuberculosisRefeeding SyndromeMalnutrition

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 25, 2018

Study Start

November 23, 2017

Primary Completion

February 14, 2018

Study Completion

February 14, 2018

Last Updated

May 25, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)