Rumah Sakit Umum Pusat Persahabatan
Jakarta, DKI Jakarta, 13230, Indonesia
NCT Number: NCT07058233
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).
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Notify Me15 year–65 year
All sexes
Interventional
Not applicable
Jakarta, DKI Jakarta, 13230, Indonesia
Tuberculosis (TB) is linked to poverty, malnutrition, and reduced immunity, with malnutrition both contributing to and resulting from TB.1-3 Active TB increases energy needs, causes protein breakdown, and leads to muscle wasting. Malnutrition, which is common in TB patients, worsens clinical outcomes and increases the risk of death.1 TB treatments can also cause nausea and vomiting, further contributing to malnutrition.4 Thus integrated management is essential for successful treatment.
In India, 68.6% of MDR-TB patients without HIV infection are malnourished, a prevalence comparable to that observed among MDR-TB patients at Persahabatan General Hospital, Jakarta, Indonesia (51.8%).5,6 Malnourished MDR TB patients have worse clinical outcomes, more side effects, and a higher risk of death.7 A BMI under 18.5 kg/m2 and inadequate weight gain during treatment indicate a poor response and increased risk of recurrence.1 Failure to gain weight (≤ 5%) in the first two months of treatment has been demonstrated to be linked to TB recurrence.8 Oral nutritional supplements have demonstrated the potential to improve nutritional status, muscle strength, and immunity, thus potentially facilitating an accelerated treatment process. Studies have also shown that nutritional supplements can improve BMI and gamma interferon levels.9 However, some studies have indicated that despite increased macronutrient intake, MDR TB patients may still experience a decline in body weight.10 This study aims to evaluate whether oral nutritional supplements providing 705 kcal and 30.5 grams of protein daily during the first two months can increase body weight and improve other clinical outcomes of MDR TB patients, including the impact of supplementation on albumin, globulin, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Nutritional Supplement (ONS) in the form of a soy-based drink (235 kcal/200mL: 10.34 g protein, 7.9 g fat, 30.61 g carbohydrate; Protein)
Time frame: Pre intervention and post intervention (at 60 days)
A change in body weight in kg
Time frame: From enrollment to 60 days after enrollment
Daily food intake of total energy, protein, fat, and carbohydrates. The subjects were given a form to record food intake 3 times a week (2 working days and 1 day off) for 8 weeks including the type and amount of food measured using standard units of spoons, glasses, etc. Furthermore, the intake data was converted into grams using a food ingredient analysis list and then analyzed using the 2007 nutrisurvey.
Time frame: Pre intervention and post intervention (at 60 days)
Serum albumin is measured by taking peripheral venous blood samples with units of g/dL.
Time frame: Pre intervention and post intervention (at 60 days)
CRP is measured by taking peripheral venous blood samples in mg/dL units.
Time frame: Pre intervention and post intervention (at 60 days)
Total protein is measured using a peripheral venous blood sample in g/dL units.
Time frame: Pre intervention and post intervention (at 60 days)
Erythrocyte sedimentation rate is measured using a peripheral venous blood sample in mm/hour units.
RSUP Persahabatan
Other
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