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Completed

NCT Number: NCT05953636

Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes in hemodialysis patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

About this study

Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life.

Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.

It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult hemodialysis patients (≥18 years of age).
  • Received dialysis for at least 6 months prior to study screening.
  • Receive hemodialysis at least 3 times per week .

Exclusion criteria

  • Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
  • Participants with an allergy to any ingredients in the nutritional supplements.
  • Significant edema and fluid overload.
  • Hepatic patients.

Treatment and study plan

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

Dietary Supplement

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )

Primary outcomes

  1. effect on nutritional status

    Time frame: 6 weeks

    assessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)

  2. effect on blood pressure

    Time frame: 6 weeks

    systolic and diastolic Blood pressure change at 6 weeks from baseline

  3. effect on dialysis adequacy

    Time frame: 6 weeks

    Estimation of Kt/V change at 6 weeks from baseline

Secondary outcomes

  1. effect on BMI

    Time frame: 6 weeks

    BMI assessment change at 6 weeks from baseline

  2. effect on serum albumin

    Time frame: 6 weeks

    • serum albumin change at 6 weeks from baseline

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

The Effect of Different Timings of Protein Supplementation on Variable Outcomes in Hemodialysis Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2023
Registry last updated
Jul 1, 2024

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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