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

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

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.

Study Overview

• Status: Terminated
• Conditions: Malnutrition; Tuberculosis; Tuberculosis, Pulmonary; Undernutrition
• Intervention / Treatment: Dietary supplement: Lacprodan® DI-8090

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilie B Patsche; Phone Number: +245956221717; Email: ceciliepatsche@live.dk

Study Locations

• Guinea-Bissau
  • Denmark
    • Bissau, Denmark, Guinea-Bissau, 1004
      • The Bandim Health Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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	Dietary supplement: Lacprodan® DI-8090; Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry	Proportion of patients with BMI gain >9% at end of treatment	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Bandim Health Project; Arla Foods
• Investigators: Principal Investigator: Cecilie B Patsche, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Nutritional Supplement; Health-related Quality of Life; Dietary Intake
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Nutrition Disorders; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Malnutrition
• Other Study ID Numbers: 1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No