Treating Tuberculosis Wasting With a High-protein Supplement

• Register: ClinicalTrials.gov
• Last refreshed on: 18 September 2023
• Main ID: NCT03302949
• Date of registration: 02/10/2017
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Treating Tuberculosis Wasting With a High-protein Supplement NUTRIATO
• Scientific title: Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome
• Date of first enrolment: August 1, 2017
• Target sample size: 232
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03302949
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Guinea-Bissau

Contacts

• Name: Cecilie B Patsche
• Affiliation: University of Aarhus

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Undernutrition

Tuberculosis, Pulmonary

Malnutrition

Intervention(s)

Dietary Supplement: Lacprodan® DI-8090

Primary Outcome(s)

Anthropometry [Time Frame: 6 months]

Secondary Outcome(s)

Diet [Time Frame: 6 months]

Anthropometry [Time Frame: 2 years]

Health-related quality of life [Time Frame: 6 months]

Treatment outcome [Time Frame: 2 years]

Treatment Outcome [Time Frame: 6 months]

Secondary ID(s)

1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Arla Foods

Bandim Health Project