NCT03302949

Treating Tuberculosis Wasting With a High-protein Supplement

Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lacprodan® DI-8090	Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.

Timeline

• Start date: 2017-08-01
• Primary completion: 2022-11-01
• Completion: 2023-01-30
• First posted: 2017-10-05
• Last updated: 2023-09-11

Locations

1 site across 1 country: Guinea-Bissau