Oral Nutritional Supplementation in Hospital Patients

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Other: Nutritional beverage 10003RF; Other: Dietary Counseling

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)

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh, India
    • King George Hospital / Andhra Medical College
  • Andhra Pradesh, India
    • St. Theresa's Hospital
  • Hyderabad, India
    • Care Hospital- Hyderabad
  • Kolkata, India
    • Advanced Medicare and Research Institute
  • Maharashtra, India
    • Sengupta Hospital & Research Institute
  • Mumbai, 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
  • Nagpur, India
    • Abhinav Hospital
  • New Delhi, India
    • Sir Ganga Ram Hospital
  • Noida, India
    • Metro Multispecialty Hospital- X-1,Sector
  • Pune, India
    • Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
  • Punjab, India
    • Immunology at Dayanand Medical College & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary Counseling	Other: Dietary Counseling; Guidelines for dietary counseling include energy and nutrient requirements.
Experimental: Dietary Counseling + ONS	Other: Nutritional beverage 10003RF; 2 sachets per day; Other: Dietary Counseling; Guidelines for dietary counseling include energy and nutrient requirements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in Body weight	baseline and weeks 4, 8, 12

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Vinita Satyavrat, MD, Abbott Nutrition International-India

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BK83