NUTRIATO: Treating Tuberculosis Wasting With a High-protein Supplement

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT03302949
Collaborator
Bandim Health Project (Other), Arla Foods (Industry)
260
1
2
77
3.4

Study Details

Study Description

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
  • Dietary Supplement: Lacprodan® DI-8090
N/A

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

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2017
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Anthropometry [6 months]

    Proportion of patients with BMI gain >9% at end of treatment

Secondary Outcome Measures

  1. Treatment Outcome [6 months]

    Defined by WHO criteria (incl. mortality), at end of treatment

  2. Treatment outcome [2 years]

    Defined by WHO criteria (incl. mortality), at 2-year follow up

  3. Anthropometry [2 years]

    Proportion of patients with sustained BMI gain >9% at 2-year follow up

  4. Diet [6 months]

    Assesment of daily energy intake (kJ) of patients with tuberculosis using sq-FFQ

  5. Health-related quality of life [6 months]

    Score obtained from SF-36

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Bandim Health Project Bissau Denmark Guinea-Bissau 1004

Sponsors and Collaborators

  • University of Aarhus
  • Bandim Health Project
  • Arla Foods

Investigators

  • Principal Investigator: Cecilie B Patsche, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT03302949
Other Study ID Numbers:
  • 1004
First Posted:
Oct 5, 2017
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022