Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With … (NCT07058233) | Clinical Trial Compass
CompletedNot Applicable
Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial
Indonesia70 participantsStarted 2022-04-01
Plain-language summary
Tuberculosis increases energy demands and protein breakdown, leading to muscle wasting. Malnutrition and minimal weight gain less than 5% in first two months predict treatment failure. Malnutrition is defined as weight loss more than 5% in three months and Body Mass Index (BMI) ≤ 20 kg/m². This study assesses weight changes with high-energy, high-protein oral nutritional supplementation (ONS).
Who can participate
Age range15 Years – 65 Years
SexALL
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Inclusion Criteria:
* Who had access to electronic devices (e.g., mobile phones) for adherence monitoring
* individuals newly diagnosed with rifampicin-resistant pulmonary tuberculosis (RR-TB), multidrug-resistant tuberculosis (MDR-TB), or pre-extensively drug-resistant tuberculosis (Pre-XDR-TB) at the drug-resistant tuberculosis outpatient clinic of Persahabatan General Hospital, Jakarta, Indonesia.
* BMI of 13-20 kg/m²
* had received standardized or individualized treatment regimens for seven days
* had no severe drug-induced hepatitis indicated by elevated liver enzymes \>5 times the normal upper limit
Exclusion Criteria:
* individuals with HIV infection,
* end-stage renal failure,
* severe anemia (hemoglobin \<8 g/dL),
* severe hypoalbuminemia (albumin \<2.5 g/dL),
* acute or chronic liver diseases (including hepatitis, cirrhosis, or jaundice),
* cancer,
* interstitial lung disease (ILD),
* anatomical gastrointestinal disorders (either congenital or post-surgical),
* diabetes mellitus,
* long-term corticosteroid or immunosuppressant therapy
* other acute pulmonary infections such as pneumonia,
* exacerbations of chronic obstructive pulmonary disease (COPD), or asthma
What they're measuring
1
Body weight
Timeframe: Pre intervention and post intervention (at 60 days)