Oral Nutritional Supplementation in Hospital Patients

Phase 3

Completed

• Conditions: Malnutrition
• Interventions: Other: Nutritional beverage 10003RF; Other: Dietary Counseling

• Registration Number: NCT01641770
• Lead Sponsor: Abbott Nutrition

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)

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Status Verified: 2012-07
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-16
• Last Update Submitted: 2012-07-16
• Study First Posted: 2012-07-17
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Counseling + ONS	Nutritional beverage 10003RF	-
Dietary Counseling + ONS	Dietary Counseling	-
Dietary Counseling	Dietary Counseling	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Body weight	baseline and weeks 4, 8, 12

Secondary Outcome Measures

Name	Time	Method
Nutrition Assessment	baseline and week 12
BMI	baseline and week 12
Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)	baseline and weeks 4,8,12	values and changes from baseline
Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)	baseline and weeks 4, 8, 12	values and changes from baseline
Blood Chemistries (glucose mg/dL, creatinine mg/dL)	Baseline and weeks 4,8,12	values and changes from baseline
Blood Chemistries (c-reactive protein mg/L)	Baseline and weeks 4,8,12	Values and changes from baseline

Trial Locations

Locations (13)

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

Metro Multispecialty Hospital- X-1,Sector; 🇮🇳 Noida, India

Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India

Immunology at Dayanand Medical College & Hospital; 🇮🇳 Punjab, India

Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital; 🇮🇳 Pune, India

St. Theresa's Hospital; 🇮🇳 Andhra Pradesh, India

King George Hospital / Andhra Medical College; 🇮🇳 Andhra Pradesh, India

TN Medical College & BYL Nair Hospital; 🇮🇳 Mumbai, India

Abhinav Hospital; 🇮🇳 Nagpur, India