Oral Nutritional Supplementation of Hemodialysis Patients

NCT ID: NCT05333692

Last Updated: 2022-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-05-06

Brief Summary

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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®.

Detailed Description

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Conditions

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Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NEPRO®

Group Type ACTIVE_COMPARATOR

NEPRO® , Abbott

Intervention Type DIETARY_SUPPLEMENT

2-4 cans NEPRO® per day

Fresubin® Protein Energy DRINK

Group Type EXPERIMENTAL

Fresubin® Protein Energy DRINK

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fresubin® Protein Energy DRINK

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

Intervention Type DIETARY_SUPPLEMENT

NEPRO® , Abbott

2-4 cans NEPRO® per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Age 40-80 years
2. Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
3. 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

1. BMI\<18.5 and calorie intake unable to reach 50% of the recommended level
2. BMI\>30 kg/m2,
3. abnormal liver function,
4. malignant disease,
5. scheduled surgery within a month or after surgery,
6. infectious disease,
7. suboptimal tolerance of nutritional supplements,
8. inflammatory bowel disease, bowel obstruction,
9. acute condition complicated with multiple organ failure or under palliative care.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role collaborator

Fresenius Kabi Taiwan Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung Shan Medical University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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FrPE-005-IEN

Identifier Type: -

Identifier Source: org_study_id

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