Treating Tuberculosis Wasting With a High-protein Supplement

NCT ID: NCT03302949

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-01-30

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.

Detailed Description

It is hypothesized that patients with tuberculosis receiving whey protein concentrate as nutritional supplement will experience a greater gain in adverse anthropometric measures, and experience a decreased risk of relapse and death, compared with patients with tuberculosis, who do not receive nutritional supplement. 260 patients will be recruited from and included/randomized at 4 trial sites in Bissau, Guinea-Bissau (Bandim Health Center, Belem Health Center, Cuntum Health Center and Hospital Raoul Follereau). Patients randomized to the intervention arm will receive one package of whey protein concentrate (approx. 62.5g) per day for the duration of the 6-month long anti-tuberculous treatment. Patients will be followed bimonthly during the treatment period, with clinical examinations, blood sample analyses, and nutritional status and dietary intake assessments.

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Undernutrition; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Control 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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Intervention 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

Group Type: EXPERIMENTAL

Lacprodan® DI-8090

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lacprodan® DI-8090

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with TB
• Aged 18 years and above
• BMI<20

Exclusion Criteria

• Pregnancy
• Commencement of treatment ≥30 days prior to inclusion
• Decreased kidney function
• Missing informed consent
• Mentally ill/disabled patients unable to comply with the treatment/intervention regimen

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bandim Health Project

OTHER

Sponsor Role: collaborator

Arla Foods

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilie B Patsche

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

The Bandim Health Project

Bissau, Denmark, Guinea-Bissau

Countries

Guinea-Bissau

Other Identifiers

1004

Identifier Type: -

Identifier Source: org_study_id