An interventional study of Lacprodan® DI-8090 in Tuberculosis, Tuberculosis, Pulmonary and Undernutrition, sponsored by University of Aarhus. Terminated at 1 site in Guinea-Bissau. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 232 is above the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Compared within Tuberculosis, Pulmonary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tuberculosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
Anthropometry
Proportion of patients with BMI gain \>9% at end of treatment
Time frame: 6 months
Treatment Outcome
Defined by WHO criteria (incl. mortality), at end of treatment
Time frame: 6 months
Treatment outcome
Defined by WHO criteria (incl. mortality), at 2-year follow up
Time frame: 2 years
Anthropometry
Proportion of patients with sustained BMI gain \>9% at 2-year follow up
Time frame: 2 years
Diet
Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ
Time frame: 6 months
Health-related quality of life
Score obtained from SF-36
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Nov 2022, 63 months.
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This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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