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The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.
Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. Eligible subjects will be randomized into 2 treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Counseling + ONS | Experimental |
| |
| Dietary Counseling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional beverage 10003RF | Other | 2 sachets per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Body weight | baseline and weeks 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrition Assessment | baseline and week 12 | |
| BMI | baseline and week 12 | |
| Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinita Satyavrat, MD | Abbott Nutrition International-India | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King George Hospital / Andhra Medical College | Andhra Pradesh | India | ||||
| St. Theresa's Hospital |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Dietary Counseling |
| Other |
Guidelines for dietary counseling include energy and nutrient requirements. |
|
| Dietary Counseling | Other | Guidelines for dietary counseling include energy and nutrient requirements. |
|
values and changes from baseline |
| baseline and weeks 4,8,12 |
| Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL) | values and changes from baseline | baseline and weeks 4, 8, 12 |
| Blood Chemistries (glucose mg/dL, creatinine mg/dL) | values and changes from baseline | Baseline and weeks 4,8,12 |
| Blood Chemistries (c-reactive protein mg/L) | Values and changes from baseline | Baseline and weeks 4,8,12 |
| Andhra Pradesh |
| India |
| Care Hospital- Hyderabad | Hyderabad | India |
| Advanced Medicare and Research Institute | Kolkata | India |
| Sengupta Hospital & Research Institute | Maharashtra | India |
| Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital | Mumbai | India |
| Seth GS Medical College and KEM Hospital | Mumbai | India |
| TN Medical College & BYL Nair Hospital | Mumbai | India |
| Abhinav Hospital | Nagpur | India |
| Sir Ganga Ram Hospital | New Delhi | India |
| Metro Multispecialty Hospital- X-1,Sector | Noida | India |
| Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital | Pune | India |
| Immunology at Dayanand Medical College & Hospital | Punjab | India |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |