Clinical trial NCT01641770: Oral Nutritional Supplementation in Hospital Patients
Official title: Oral Nutritional Supplementation in Hospital Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Changes from baseline in Body weight
timeFrame: baseline and weeks 4, 8, 12
Secondary outcomes:
measure: Nutrition Assessment
timeFrame: baseline and week 12
measure: BMI
timeFrame: baseline and week 12
measure: Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)
timeFrame: baseline and weeks 4,8,12
measure: Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)
timeFrame: baseline and weeks 4, 8, 12
measure: Blood Chemistries (glucose mg/dL, creatinine mg/dL)
timeFrame: Baseline and weeks 4,8,12
measure: Blood Chemistries (c-reactive protein mg/L)
timeFrame: Baseline and weeks 4,8,12
Other outcomes:
Locations:
city: Andhra Pradesh
country: India
facility: King George Hospital / Andhra Medical College
city: Andhra Pradesh
country: India
facility: St. Theresa's Hospital
city: Hyderabad
country: India
facility: Care Hospital- Hyderabad
city: Kolkata
country: India
facility: Advanced Medicare and Research Institute
city: Maharashtra
country: India
facility: Sengupta Hospital & Research Institute
city: Mumbai
country: India
facility: Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital
city: Mumbai
country: India
facility: Seth GS Medical College and KEM Hospital
city: Mumbai
country: India
facility: TN Medical College & BYL Nair Hospital
city: Nagpur
country: India
facility: Abhinav Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Noida
country: India
facility: Metro Multispecialty Hospital- X-1,Sector
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
city: Punjab
country: India
facility: Immunology at Dayanand Medical College & Hospital
Study officials:
affiliation: Abbott Nutrition International-India
name: Vinita Satyavrat, MD
role: STUDY_CHAIR
References: