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| ID | Type | Description | Link |
|---|---|---|---|
| Otsuka Holding | Other Identifier | Oral Nutritional Supplementation | |
| Global Fund to Fight AIDS, TB | Other Identifier | Infection Disease |
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| Name | Class |
|---|---|
| Otsuka Holdings Co., Ltd. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | standard 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; Otsuka) with the instruction to consume three (3) sachets per day (total of 705 kcal and 31 grams of protein) plus standard treatment. |
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| Control group | No Intervention | standard treatment only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutritional supplementation | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | A change in body weight in kg | Pre intervention and post intervention (at 60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily food intake | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fathiyah Isbaniah Sp.P(K), Dr., dr. | Department of Pulmonology and Respiratory Medicine Faculty of Medicine, Universitas Indonesia, Persahabatan General Hospital, Jakarta | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rumah Sakit Umum Pusat Persahabatan | Jakarta | DKI Jakarta | 13230 | Indonesia |
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one group intervention (standard treatment + Oral Nutritional Supplementation) and one group placebo (standard treatment only)
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| From enrollment to 60 days after enrollment |
| Albumin | Serum albumin is measured by taking peripheral venous blood samples with units of g/dL. | Pre intervention and post intervention (at 60 days) |
| CRP | CRP is measured by taking peripheral venous blood samples in mg/dL units. | Pre intervention and post intervention (at 60 days) |
| Total protein | Total protein is measured using a peripheral venous blood sample in g/dL units. | Pre intervention and post intervention (at 60 days) |
| ESR | Erythrocyte sedimentation rate is measured using a peripheral venous blood sample in mm/hour units. | Pre intervention and post intervention (at 60 days) |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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