Oral Nutritional Supplementation in Hospital Patients

Abbott

Status and phase

Completed

Phase 3

Conditions

Malnutrition

Treatments

Other: Nutritional beverage 10003RF

Other: Dietary Counseling

Study type

Interventional

Funder types

Industry

Identifiers

NCT01641770

BK83

Details and patient eligibility

About

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.

Full 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)

Enrollment

212 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.