Treating Tuberculosis Wasting With a High-protein Supplement

Tuberculosis Clinical Trial

— NUTRIATO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03302949
• Other study ID #: 1004
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: January 30, 2023

Study information

• Verified date: September 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: January 30, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Tuberculosis
• Tuberculosis, Pulmonary
• Undernutrition

Intervention

Dietary Supplement:
• Lacprodan® DI-8090
Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.

Locations

Country	Name	City	State
Guinea-Bissau	The Bandim Health Project	Bissau	Denmark

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Arla Foods, Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometry	Proportion of patients with BMI gain >9% at end of treatment	6 months
Secondary	Treatment Outcome	Defined by WHO criteria (incl. mortality), at end of treatment	6 months
Secondary	Treatment outcome	Defined by WHO criteria (incl. mortality), at 2-year follow up	2 years
Secondary	Anthropometry	Proportion of patients with sustained BMI gain >9% at 2-year follow up	2 years
Secondary	Diet	Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ	6 months
Secondary	Health-related quality of life	Score obtained from SF-36	6 months