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Completed

NCT Number: NCT01641770

Oral Nutritional Supplementation in Hospital Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King George Hospital / Andhra Medical College, Andhra Pradesh, India

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional beverage 10003RF

Other

2 sachets per day

Dietary Counseling

Other

Guidelines for dietary counseling include energy and nutrient requirements.

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)

    Time frame: baseline and weeks 4,8,12

    values and changes from baseline

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

    Time frame: baseline and weeks 4, 8, 12

    values and changes from baseline

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

    Time frame: Baseline and weeks 4,8,12

    values and changes from baseline

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

    Time frame: Baseline and weeks 4,8,12

    Values and changes from baseline

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2012
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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