Treating Tuberculosis Wasting With a High-protein Supplement

Not Applicable

Terminated

• Conditions: Tuberculosis, Pulmonary; Malnutrition; Tuberculosis; Undernutrition
• Interventions: Dietary Supplement: Lacprodan® DI-8090

• Registration Number: NCT03302949
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Primary Completion: 2022-11-01
• Study Completion: 2023-01-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Lacprodan® DI-8090	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

Primary Outcome Measures

Name	Time	Method
Anthropometry	6 months	Proportion of patients with BMI gain \>9% at end of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Bandim Health Project; 🇬🇼 Bissau, Denmark, Guinea-Bissau