NCT01641770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

9 months

First QC Date

July 11, 2012

Last Update Submit

July 16, 2012

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in Body weight

    baseline and weeks 4, 8, 12

Secondary Outcomes (6)

  • 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

  • Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)

    baseline and weeks 4, 8, 12

  • Blood Chemistries (glucose mg/dL, creatinine mg/dL)

    Baseline and weeks 4,8,12

  • +1 more secondary outcomes

Study Arms (2)

Dietary Counseling + ONS

EXPERIMENTAL
Other: Nutritional beverage 10003RFOther: Dietary Counseling

Dietary Counseling

ACTIVE COMPARATOR
Other: Dietary Counseling

Interventions

Nutritional beverage 10003RFOTHER

2 sachets per day

Dietary Counseling + ONS
Dietary CounselingOTHER

Guidelines for dietary counseling include energy and nutrient requirements.

Dietary Counseling + ONS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

King George Hospital / Andhra Medical College

Andhra Pradesh, India

Location

St. Theresa's Hospital

Andhra Pradesh, India

Location

Care Hospital- Hyderabad

Hyderabad, India

Location

Advanced Medicare and Research Institute

Kolkata, India

Location

Sengupta Hospital & Research Institute

Maharashtra, India

Location

Lokmanya Tilak Muncipal Medical College & Lokmanya Thilak Municipal General Hospital

Mumbai, India

Location

Seth GS Medical College and KEM Hospital

Mumbai, India

Location

TN Medical College & BYL Nair Hospital

Mumbai, India

Location

Abhinav Hospital

Nagpur, India

Location

Sir Ganga Ram Hospital

New Delhi, India

Location

Metro Multispecialty Hospital- X-1,Sector

Noida, India

Location

Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital

Pune, India

Location

Immunology at Dayanand Medical College & Hospital

Punjab, India

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Vinita Satyavrat, MD

    Abbott Nutrition International-India

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 17, 2012

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

IN(13)