CClinicalTrials.gg
CompletedNCT01641770Updated Jul 17, 2012

Oral Nutritional Supplementation in Hospital Patients

A Phase 3 interventional study of Nutritional beverage 10003RF and Dietary Counseling in Malnutrition, sponsored by Abbott Nutrition. Completed at 13 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-17.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Malnutrition

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 212 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Dietary Counseling + ONS

    Other: Nutritional beverage 10003RF · Other: Dietary Counseling

  • Active comparator
    Dietary Counseling

    Other: Dietary Counseling

Interventions

  • OtherNutritional beverage 10003RF

    2 sachets per day

  • OtherDietary Counseling

    Guidelines for dietary counseling include energy and nutrient requirements.

  • OtherDietary Counseling

    Guidelines for dietary counseling include energy and nutrient requirements.

06

What researchers measure

Primary outcomes

  1. Changes from baseline in Body weight

    Time frame: baseline and weeks 4, 8, 12

Secondary outcomes

  1. Nutrition Assessment

    Time frame: baseline and week 12

  2. BMI

    Time frame: baseline and week 12

  3. Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)

    values and changes from baseline

    Time frame: baseline and weeks 4,8,12

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

    values and changes from baseline

    Time frame: baseline and weeks 4, 8, 12

  5. Blood Chemistries (glucose mg/dL, creatinine mg/dL)

    values and changes from baseline

    Time frame: Baseline and weeks 4,8,12

  6. Blood Chemistries (c-reactive protein mg/L)

    Values and changes from baseline

    Time frame: Baseline and weeks 4,8,12

07

Study locations

13 sites
  • 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, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01641770
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Jul 17, 2012
Start date
Oct 2010
Primary completion
Jul 2011
Completion
Oct 2011
Last update
Jul 17, 2012

Study contacts

Vinita Satyavrat, MD
study chair · Abbott Nutrition International-India

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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