Treating Tuberculosis Wasting With a High-protein Supplement

NCT03302949 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Undernutrition
  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Lacprodan® DI-8090

Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.

Sponsors & Collaborators

  • Bandim Health Project

    collaborator OTHER
  • Arla Foods

    collaborator INDUSTRY
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Cecilie B Patsche · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-11-01
Completion
2023-01-30

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302949 on ClinicalTrials.gov