Study Stopped
Study enrollment stopped before reaching sample size due to time constraints. Follow up visits and intervention was given per protocol to all included participants.
Treating Tuberculosis Wasting With a High-protein Supplement
NUTRIATO
Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome
1 other identifier
interventional
232
1 country
1
Brief Summary
Undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an increased relapse risk. The purpose of this study is to test the effect of Lacprodan® DI-8090 whey protein concentrate on anthropometric measures, treatment outcome and health-related quality of life, against standard practice during anti-tuberculous treatment on patients with a BMI \<20 living in Guinea-Bissau.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
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
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedSeptember 11, 2023
September 1, 2023
5.3 years
October 2, 2017
September 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anthropometry
Proportion of patients with BMI gain \>9% at end of treatment
6 months
Secondary Outcomes (5)
Treatment Outcome
6 months
Treatment outcome
2 years
Anthropometry
2 years
Diet
6 months
Health-related quality of life
6 months
Study Arms (2)
Control
NO INTERVENTIONControl arm will not receive the intervention, but will receive standard 6-month anti-tuberculosis regimen and nutritional supplements provided by various NGO's (on irregular basis).
Intervention
EXPERIMENTALIntervention arm will receive standard 6-month anti-tuberculosis regimen, nutritional supplements provided by various NGO's (on irregular basis), and receive the study intervention of daily supplement of 62.5g Lacprodan® DI-8090
Interventions
Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with TB
- Aged 18 years and above
- BMI\<20
You may not qualify if:
- Pregnancy
- Decreased kidney function
- Missing informed consent
- Mentally ill/disabled patients unable to comply with the treatment/intervention regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Bandim Health Projectcollaborator
- Arla Foodscollaborator
Study Sites (1)
The Bandim Health Project
Bissau, Denmark, 1004, Guinea-Bissau
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilie B Patsche
University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2017
First Posted
October 5, 2017
Study Start
August 1, 2017
Primary Completion
November 1, 2022
Study Completion
January 30, 2023
Last Updated
September 11, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share