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OpenTrials
Completed

NCT Number: NCT05469620

Adaptive Nutrition Therapy in Hemodialysis

8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.

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Key information

Conditions

Renal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inje University Seoul Paik Hospital

Seoul, 100-032, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have been on hemodialysis for over 3 months

Exclusion criteria

  • diagnosed with cancer within 5 years

Treatment and study plan

Meal

Dietary Supplement

Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.

Education

Other

Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.

Primary outcomes

  1. Potassium

    Time frame: 4 weeks

    Serum potassium level measured from routine blood test.

  2. Phosphate

    Time frame: 4 weeks

    Serum phosphate level measured from routine blood test.

  3. Malnutrition

    Time frame: 8 weeks

    10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition)

Secondary outcomes

  1. Depression

    Time frame: 8 weeks

    21-item depression score measured with Korean-Beck Depression Inventory. Scores rnage from 0 to 63, higher value corresponding to worse outcome (severe depression).

  2. Self-Efficacy

    Time frame: 8 weeks

    10-item Self-Efficacy score for hemodialysis patients. Scores range from 10 to 40, higher values corresponding to better outcome (higher self-efficacy).

Sponsors and collaborators

Lead sponsor

Inje University

Other

Collaborators

  • Daejeon Eulji University Medical Center
  • Eatmapl
  • Hallym University Kangnam Sacred Heart Hospital
  • KangWon National University Hospital
  • Korea Data Agency
  • Korea University Ansan Hospital
  • Korea University Guro Hospital
  • Myongji Hospital
  • Seoul National University

Registry information

Official study title

Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 22, 2022
Registry last updated
Jul 22, 2022

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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