Oral Nutritional Supplementation in Hospital Patients

Malnutrition Clinical Trial

Official title:

Oral Nutritional Supplementation in Hospital Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641770
• Other study ID #: BK83
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2012
• Last updated: July 16, 2012
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2012
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Nutritional beverage 10003RF
2 sachets per day
• Dietary Counseling
Guidelines for dietary counseling include energy and nutrient requirements.
• Dietary Counseling
Guidelines for dietary counseling include energy and nutrient requirements.

Locations

Country	Name	City	State
India	King George Hospital / Andhra Medical College	Andhra Pradesh
India	St. Theresa's Hospital	Andhra Pradesh
India	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	TN Medical College & BYL Nair Hospital	Mumbai
India	Abhinav Hospital	Nagpur
India	Sir Ganga Ram Hospital	New Delhi
India	Metro Multispecialty Hospital- X-1,Sector	Noida
India	Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital	Pune
India	Immunology at Dayanand Medical College & Hospital	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Body weight		baseline and weeks 4, 8, 12	No
Secondary	Nutrition Assessment		baseline and week 12	No
Secondary	BMI		baseline and week 12	No
Secondary	Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)	values and changes from baseline	baseline and weeks 4,8,12	No
Secondary	Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)	values and changes from baseline	baseline and weeks 4, 8, 12	No
Secondary	Blood Chemistries (glucose mg/dL, creatinine mg/dL)	values and changes from baseline	Baseline and weeks 4,8,12	No
Secondary	Blood Chemistries (c-reactive protein mg/L)	Values and changes from baseline	Baseline and weeks 4,8,12	No