MedDataX Logo

Oral Nutritional Supplementation in Hospital Patients

NCT ID: NCT01641770

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary Counseling + ONS

Group Type EXPERIMENTAL

Nutritional beverage 10003RF

Intervention Type OTHER

2 sachets per day

Dietary Counseling

Intervention Type OTHER

Guidelines for dietary counseling include energy and nutrient requirements.

Dietary Counseling

Group Type ACTIVE_COMPARATOR

Dietary Counseling

Intervention Type OTHER

Guidelines for dietary counseling include energy and nutrient requirements.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional beverage 10003RF

2 sachets per day

Intervention Type OTHER

Dietary Counseling

Guidelines for dietary counseling include energy and nutrient requirements.

Intervention Type OTHER

Dietary Counseling

Guidelines for dietary counseling include energy and nutrient requirements.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vinita Satyavrat, MD

Role: STUDY_CHAIR

Abbott Nutrition International-India

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King George Hospital / Andhra Medical College

Andhra Pradesh, , India

Site Status

St. Theresa's Hospital

Andhra Pradesh, , India

Site Status

Care Hospital- Hyderabad

Hyderabad, , India

Site Status

Advanced Medicare and Research Institute

Kolkata, , India

Site Status

Sengupta Hospital & Research Institute

Maharashtra, , India

Site Status

Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital

Mumbai, , India

Site Status

Seth GS Medical College and KEM Hospital

Mumbai, , India

Site Status

TN Medical College & BYL Nair Hospital

Mumbai, , India

Site Status

Abhinav Hospital

Nagpur, , India

Site Status

Sir Ganga Ram Hospital

New Delhi, , India

Site Status

Metro Multispecialty Hospital- X-1,Sector

Noida, , India

Site Status

Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital

Pune, , India

Site Status

Immunology at Dayanand Medical College & Hospital

Punjab, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BK83

Identifier Type: -

Identifier Source: org_study_id