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Effect of Access to Dietary Intervention in a Dialysis Unit

NCT06996405 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-30

No results posted yet for this study

Summary

Objective:

The aim of this study is to explore the effect of access to individual dietary counselling by a dietitian in the dialysis unit on biochemical values (phosphorus and potassium), diet, nutritional status, quality of life (QoL) and health literacy (HL).

Hypothesis: Having access to a dietitian can better laboratory values and affect dietary intake, nutritional status, QoL and HL in a positive matter.

Method:

Pilot cluster RCT study in three the dialysis units in Region Zealand. Clustering of people on dialysis the same day to either intervention or control group. The groups is expected to be similar regarding clinical characteristics.

Primary outcome: Change in average p-phosphate Secondary outcomes: Change in average p-potassium, number of phosphate binders, number of potassium binders, HeartDiet-score, Nutritional Status, Adherence to diet (End Stage Renal Disease Adherence Questionnaire), Quality of life (Kidney Disease Quality of Life Short Form) and Health literacy (Health Literacy Questionnaire)

Intervention:

The intervention group receives an initial individual dietary interview, monthly follow-up and weekly access to a dietitian in the dialysis unit for four months. The control group receives usual care with referral to a dietitian when needed.

Conditions

  • Dialysis
  • Diabetes
  • Nutritional Status
  • Diet Therapy

Interventions

OTHER

Access to dietary treatment

Dietary treatment using current nutrition guidelines, dialogic communication and Nutrition Care Process repeatedly by weekly access to a dietitian for four month.

Sponsors & Collaborators

  • Steno Diabetes Center Sjaelland

    collaborator OTHER_GOV

  • The Danish Kidney Association

    collaborator OTHER

  • VIA University College

    collaborator OTHER

  • The Danish Dietetic Association

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Sofie Wendelboe · Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06996405 on ClinicalTrials.gov