Protein Supplementation During Dialysis (PROSED) (NCT07237997) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Protein Supplementation During Dialysis (PROSED)
United Kingdom114 participantsStarted 2026-01-05
Plain-language summary
When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.
Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years (no upper age limit)
* Patients receiving maintenance dialysis for ≥ three months
* Ability to provide informed consent
Exclusion Criteria:
* Anticipated live donor kidney transplant and/or kidney recovery within the period of sample collection.
* Anticipated change of dialysis modality within the period of sample collection
* Severe malnutrition based on either:
* Renal 7-point Subjective Global Assessment (SGA) scores of 1-2
* Global Leadership Initiative Malnutrition (GLIM) Stage 2
* Protein-losing enteropathy.
* Persistent nephrotic syndrome with \>3g/day urinary protein loss.
* Active wounds or burns contributing to protein losses as judged by the investigator.
* Current active acute inflammatory illness (likely to have catabolic effect in the opinion of the investigator).
* Current malignancy based on recent (\<12 months) diagnosis and/or active treatment for malignancy and/or planned treatment for malignancy, excluding non-melanoma skin cancers.
* Pregnancy (current or planned within duration of study) or breast feeding.
* People with swallowing difficulties precluding safe ingestion (International Dysphagia Diet Standardization Initiative (IDDSI) level 0 thin fluid).
* People receiving intradialytic parenteral nutrition or intra-peritoneal amino acids, or any other forms of artificial feeding
* People prescribed levodopa
* People who are receiving chronic glucocorticoid therapy (\>10mg day prednisolone or equivalent for \>7…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.