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NCT06996405: EFFECTdiet

Effect of Access to Dietary Intervention in a Dialysis Unit

ENROLLING BY INVITATION NA Last updated 30 May 2025
What this trial tests

NA trial testing Access to dietary treatment in Dialysis in 40 participants. Enrolling by invitation.

Timeline
27 November 2024
Primary endpoint
30 September 2026
30 September 2026

Quick facts

Lead sponsorZealand University Hospital
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date27 November 2024
Primary completion30 September 2026
Estimated completion30 September 2026
Sites3 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Zealand University Hospital

Who can join

Eligibility, any sex, with Dialysis or Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Dialysis

Currently open trials in the same condition.

Other Zealand University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06996405.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing