NCT06996405

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2024Sep 2026

Study Start

First participant enrolled

November 27, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

April 11, 2025

Last Update Submit

May 21, 2025

Conditions

DialysisDiabetesNutritional StatusDiet Therapy

Keywords

Dietary interventionDietitian

Outcome Measures

Primary Outcomes (1)

  • Average phosphate

    Difference in average phosphate-level between groups

    At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)

Secondary Outcomes (13)

  • Phosphate-level

    At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)

  • Phosphate-level

    At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)

  • Phosphate binders

    At baseline, changes within the intervention period, after 5 month at the end of the intervention period, and 6 and 12 month after the last day of the intervention

  • Average potassium

    At baseline and after 5 month at the end of the intervention period (last potassium value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)

  • Potassium-level

    At baseline and after 5 month at the end of the intervention period (last potassium value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)

  • +8 more secondary outcomes

Study Arms (2)

Nutritional therapy

ACTIVE COMPARATOR

Access to diet intervention

Other: Access to dietary treatment

Usual care

NO INTERVENTION

Usual care. Referral to dietitian if needed

Interventions

Access to dietary treatmentOTHER

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

Nutritional therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand Danish
  • Chronic dialysis treatment (min. 3 month)

You may not qualify if:

  • Dementia
  • Not able to sign a consent form
  • Expected short duration of life, eg. terminal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Holbæk Dialysis Unit

Holbæk, 4300, Denmark

Location

Næstved Dialysis Unit

Næstved, 4700, Denmark

Location

Slagelse Dialysis Unit

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sofie Wendelboe

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ph.d. student/ dietitian

Study Record Dates

First Submitted

April 11, 2025

First Posted

May 30, 2025

Study Start

November 27, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)