TuberculosisNUTRIATONCT03302949
Treating Tuberculosis Wasting With a High-protein Supplement
A study testing Lacprodan® DI-8090 in people with Tuberculosis and Tuberculosis, Pulmonary, run by University of Aarhus at 1 site in Guinea-Bissau.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, Undernutrition
- What is being tested?
- Lacprodan® DI-8090
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 1 Aug 2017to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with TB
- Aged 18 years and above
- BMI<20
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Undernutrition, Malnutrition
- Being tested
- Lacprodan® DI-8090
- Keywords
- Nutritional Supplement, Health-related Quality of Life, Dietary Intake
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacprodan® DI-8090Dietary supplement
Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | Experimental | 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 Receives: Dietary Supplement: Lacprodan® DI-8090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry
Proportion of patients with BMI gain >9% at end of treatment
Measured: 6 months
Secondary outcomes (5)
Treatment Outcome
Defined by WHO criteria (incl. mortality), at end of treatment
Measured: 6 months
Treatment outcome
Defined by WHO criteria (incl. mortality), at 2-year follow up
Measured: 2 years
Anthropometry
Proportion of patients with sustained BMI gain >9% at 2-year follow up
Measured: 2 years
Diet
Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ
Measured: 6 months
Health-related quality of life
Score obtained from SF-36
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Aug 2017
- Primary completion1 Nov 2022
- Study completion30 Jan 2023
Why it stopped: Study enrollment stopped before reaching sample size due to time constraints. Follow up visits and intervention was given per protocol to all included participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Bandim Health Project, Arla Foods
- Responsible party
- Sponsor
- Investigators
- Cecilie B Patsche, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302949
- Sponsor's protocol ID
- 1004
- Acronym
- NUTRIATO
- Status last verified
- Sep 2023
- First submitted
- 2 Oct 2017
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome
- ClinicalTrials.gov ID
- NCT03302949
- Acronym / sponsor ID
- NUTRIATO / 1004
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Undernutrition, Malnutrition
- Keywords
- Nutritional Supplement, Health-related Quality of Life, Dietary Intake
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment stopped before reaching sample size due to time constraints. Follow up visits and intervention was given per protocol to all included participants.
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Bandim Health Project, Arla Foods
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Experimental | Dietary Supplement: Lacprodan® DI-8090Intervention 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with TB
- Aged 18 years and above
- BMI<20
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacprodan® DI-8090Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein. | Dietary supplement | Intervention |
Primary outcome
Anthropometry
Time frame: 6 months
Proportion of patients with BMI gain >9% at end of treatment
5 secondary outcomes
Treatment Outcome
Time frame: 6 months
Treatment outcome
Time frame: 2 years
Anthropometry
Time frame: 2 years
Diet
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study enrollment stopped before reaching sample size due to time constraints. Follow up visits and intervention was given per protocol to all included participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilie B Patsche principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacprodan® DI-8090 in people with Tuberculosis and Tuberculosis, Pulmonary, run by University of Aarhus at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study enrollment stopped before reaching sample size due to time constraints. Follow up visits and intervention was given per protocol to all included participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.