Malnutrition, Tuberculosis, Tuberculosis, Pulmonary, Undernutrition
Conditions
Keywords
Nutritional Supplement, Health-related Quality of Life, Dietary Intake
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.
Interventions
DIETARY_SUPPLEMENTLacprodan® DI-8090
Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.
Sponsors
Bandim Health Project
Arla Foods
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometry | 6 months | Proportion of patients with BMI gain \>9% at end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Outcome | 6 months | Defined by WHO criteria (incl. mortality), at end of treatment |
| Treatment outcome | 2 years | Defined by WHO criteria (incl. mortality), at 2-year follow up |
| Anthropometry | 2 years | Proportion of patients with sustained BMI gain \>9% 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 |
Countries
Guinea-Bissau
Outcome results
None listed