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The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid Nutritional Supplement from Hospital Product | Experimental | This group received liquid nutritional supplement from hospital product. The product is in a form of low lactose milk ready to drink with volume 200 ml and will be given 2 times daily for 14 days. This product is consist of 1.017 kcal/ml, 10 vitamin and 9 mineral |
|
| Placebo | Placebo Comparator | This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Nutritional Supplement from Hospital Product | Dietary Supplement | Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Body Mass Index (BMI) | BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification. | 0 and 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Subjective Global Assessment (SGA) rank | SGA rank is classified to A (well nourished), B (moderately malnourished) and C (severely malnourished) and these option are chosen based on history and physical examination that are stated in the SGA form. | 0 and 14 days |
| Change of body fat percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcellus Simadibrata | Contact | 0816920448 | marcellussimadibrata57@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcellus Simadibrata | Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) | Jakarta Pusat | 10430 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2019 | Aug 1, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Standard nutritional supplement is given 2 times daily as placebo for 14 days |
|
Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA) |
| 0 and 14 days |
| Change of handgrip strength test score | Handgrip strength is assessed by handgrip strength score. | 0 and 14 days |
| Change of hemoglobin level | Hemoglobin level is obtain from laboratory test | 0 and 14 days |
| Change of prealbumin level | Prealbumin level is obtain from laboratory test | 0 and 14 days |
| Change of Blood Urea Nitrogen (BUN) level | BUN level is obtain from laboratory test | 0 and 14 days |
| Change of lipid profile level | Lipid profile level is obtain from laboratory test | 0 and 14 days |
| Change of blood glucose level | Blood glucose level is obtain from laboratory test | 0 and 14 days |