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OpenTrials
Completed

NCT Number: NCT05333692

Oral Nutritional Supplementation of Hemodialysis Patients

This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.

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Key information

Conditions

Hemodialysis Complication

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 40-80 years
  • Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
  • Malnutrition patients. Definition of Malnutrition is serum albumin level<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.

Exclusion criteria

  • BMI<18.5 and calorie intake unable to reach 50% of the recommended level
  • BMI>30 kg/m2,
  • abnormal liver function,
  • malignant disease,
  • scheduled surgery within a month or after surgery,
  • infectious disease,
  • suboptimal tolerance of nutritional supplements,
  • inflammatory bowel disease, bowel obstruction,
  • acute condition complicated with multiple organ failure or under palliative care.

Treatment and study plan

Fresubin® Protein Energy DRINK

Dietary Supplement

1-2 bottles of Fresubin® Protein Energy DRINK per day

NEPRO® , Abbott

Dietary Supplement

2-4 cans NEPRO® per day

Primary outcomes

  1. Serum Albumin level change

    Time frame: baseline, weerk 4 and week 8

Secondary outcomes

  1. Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change

    Time frame: baseline, weerk 4 and week 8

Sponsors and collaborators

Lead sponsor

Fresenius Kabi Taiwan Ltd.

Industry

Collaborators

  • Chung Shan Medical University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2022
Registry last updated
Apr 19, 2022

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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