Treating Tuberculosis Wasting With a High-protein Supplement

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tuberculosis, Tuberculosis, Pulmonary, Undernutrition, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Lacprodan® DI-8090


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Supplement, Health-related Quality of Life, Dietary Intake