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Treating Tuberculosis Wasting With a High-protein Supplement (NUTRIATO)

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ClinicalTrials.gov Identifier: NCT03302949
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborators:
Bandim Health Project
Arla Foods
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tuberculosis Tuberculosis, Pulmonary Undernutrition Malnutrition Dietary Supplement: Lacprodan® DI-8090 Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
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
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.




Primary Outcome Measures :
  1. Anthropometry [ Time Frame: 6 months ]
    Proportion of patients with BMI gain >9% at end of treatment


Secondary Outcome Measures :
  1. Treatment Outcome [ Time Frame: 6 months ]
    Defined by WHO criteria (incl. mortality), at end of treatment

  2. Treatment outcome [ Time Frame: 2 years ]
    Defined by WHO criteria (incl. mortality), at 2-year follow up

  3. Anthropometry [ Time Frame: 2 years ]
    Proportion of patients with sustained BMI gain >9% at 2-year follow up

  4. Diet [ Time Frame: 6 months ]
    Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ

  5. Health-related quality of life [ Time Frame: 6 months ]
    Score obtained from SF-36



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302949


Contacts
Contact: Cecilie B Patsche +245956221717 ceciliepatsche@live.dk

Locations
Guinea-Bissau
The Bandim Health Project Recruiting
Bissau, Denmark, Guinea-Bissau, 1004
Contact: Cecilie B Patsche    +245956221717    ceciliepatsche@live.dk   
Sponsors and Collaborators
University of Aarhus
Bandim Health Project
Arla Foods
Investigators
Principal Investigator: Cecilie B Patsche University of Aarhus

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03302949     History of Changes
Other Study ID Numbers: 1004
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Nutritional Supplement
Health-related Quality of Life
Dietary Intake

Additional relevant MeSH terms:
Tuberculosis
Malnutrition
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Nutrition Disorders
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections