Treating Tuberculosis Wasting With a High-protein Supplement (NUTRIATO)

University of Aarhus

Status: Terminated

Conditions: Tuberculosis; Malnutrition; Tuberculosis, Pulmonary; Undernutrition

Treatments: Dietary Supplement: Lacprodan® DI-8090

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03302949

1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 2 patient groups

Control

No Intervention group

Description:

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).

Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lacprodan® DI-8090