Back to resultsOral Nutritional Supplementation in Hospital Patients
Primary Purpose
Malnutrition
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Nutritional beverage 10003RF
Dietary Counseling
Dietary Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- Recently admitted into hospital ≤36 hrs.
- Identified as having "moderate malnutrition" or "severe malnutrition".
- Anticipated length of hospital stay of at least 3 days.
- Life expectancy of ≥ 12 weeks
- Able to consume foods and beverages orally.
- Willing to abstain from nutritional supplements throughout the study period unless provided be study.
Exclusion Criteria:
- Alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy.
- Ascites, pleural effusion, severe edema or dehydration.
- Severe edema.
- Medications/ supplements/substances that could profoundly modulate metabolism or weight
- Active tuberculosis, acute Hepatitis B or C, or HIV.
Sites / Locations
- King George Hospital / Andhra Medical College
- St. Theresa's Hospital
- Care Hospital- Hyderabad
- Advanced Medicare and Research Institute
- Sengupta Hospital & Research Institute
- Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital
- Seth GS Medical College and KEM Hospital
- TN Medical College & BYL Nair Hospital
- Abhinav Hospital
- Sir Ganga Ram Hospital
- Metro Multispecialty Hospital- X-1,Sector
- Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
- Immunology at Dayanand Medical College & Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dietary Counseling + ONS
Dietary Counseling
Arm Description
Outcomes
Primary Outcome Measures
Changes from baseline in Body weight
Secondary Outcome Measures
Nutrition Assessment
BMI
Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)
values and changes from baseline
Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)
values and changes from baseline
Blood Chemistries (glucose mg/dL, creatinine mg/dL)
values and changes from baseline
Blood Chemistries (c-reactive protein mg/L)
Values and changes from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01641770
Brief Title
Oral Nutritional Supplementation in Hospital Patients
Official Title
Oral Nutritional Supplementation in Hospital Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
Dietary Counseling only (n=106)
Dietary Counseling + ONS (n=106)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Counseling + ONS
Arm Type
Experimental
Arm Title
Dietary Counseling
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Nutritional beverage 10003RF
Intervention Description
2 sachets per day
Intervention Type
Other
Intervention Name(s)
Dietary Counseling
Intervention Description
Guidelines for dietary counseling include energy and nutrient requirements.
Intervention Type
Other
Intervention Name(s)
Dietary Counseling
Intervention Description
Guidelines for dietary counseling include energy and nutrient requirements.
Primary Outcome Measure Information:
Title
Changes from baseline in Body weight
Time Frame
baseline and weeks 4, 8, 12
Secondary Outcome Measure Information:
Title
Nutrition Assessment
Time Frame
baseline and week 12
Title
BMI
Time Frame
baseline and week 12
Title
Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)
Description
values and changes from baseline
Time Frame
baseline and weeks 4,8,12
Title
Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)
Description
values and changes from baseline
Time Frame
baseline and weeks 4, 8, 12
Title
Blood Chemistries (glucose mg/dL, creatinine mg/dL)
Description
values and changes from baseline
Time Frame
Baseline and weeks 4,8,12
Title
Blood Chemistries (c-reactive protein mg/L)
Description
Values and changes from baseline
Time Frame
Baseline and weeks 4,8,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age
Recently admitted into hospital ≤36 hrs.
Identified as having "moderate malnutrition" or "severe malnutrition".
Anticipated length of hospital stay of at least 3 days.
Life expectancy of ≥ 12 weeks
Able to consume foods and beverages orally.
Willing to abstain from nutritional supplements throughout the study period unless provided be study.
Exclusion Criteria:
Alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy.
Ascites, pleural effusion, severe edema or dehydration.
Severe edema.
Medications/ supplements/substances that could profoundly modulate metabolism or weight
Active tuberculosis, acute Hepatitis B or C, or HIV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinita Satyavrat, MD
Organizational Affiliation
Abbott Nutrition International-India
Official's Role
Study Chair
Facility Information:
Facility Name
King George Hospital / Andhra Medical College
City
Andhra Pradesh
Country
India
Facility Name
St. Theresa's Hospital
City
Andhra Pradesh
Country
India
Facility Name
Care Hospital- Hyderabad
City
Hyderabad
Country
India
Facility Name
Advanced Medicare and Research Institute
City
Kolkata
Country
India
Facility Name
Sengupta Hospital & Research Institute
City
Maharashtra
Country
India
Facility Name
Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital
City
Mumbai
Country
India
Facility Name
Seth GS Medical College and KEM Hospital
City
Mumbai
Country
India
Facility Name
TN Medical College & BYL Nair Hospital
City
Mumbai
Country
India
Facility Name
Abhinav Hospital
City
Nagpur
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
Country
India
Facility Name
Metro Multispecialty Hospital- X-1,Sector
City
Noida
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
City
Pune
Country
India
Facility Name
Immunology at Dayanand Medical College & Hospital
City
Punjab
Country
India
12. IPD Sharing Statement
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Oral Nutritional Supplementation in Hospital Patients
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