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CompletedNCT07896876Updated Oct 27, 2026

Selenium, Sarcopenia, and Frailty in Hemodialysis

An observational study in Frailty, Sarcopenia and Selenium, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Ankara City Hospital Bilkent · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
78
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Chronic kidney disease (CKD) is a significant public health issue with an increasing prevalence worldwide. In patients undergoing hemodialysis (HD) in particular, various factors-such as chronic inflammation, oxidative stress, nutritional disorders, and micronutrient deficiencies-can negatively affect muscle health and physical function. Selenium, an essential trace element with potent antioxidant properties, has been shown to be present at low levels in these patients and may be associated with muscle strength. Sarcopenia and frailty are critical clinical conditions in HD patients that diminish quality of life and increase the risk of hospitalization and mortality. This study aims to evaluate the relationship between serum selenium levels, sarcopenia, and frailty in patients undergoing chronic hemodialysis, and to investigate whether selenium levels might serve as a potential biomarker for these clinical conditions.

Read the detailed description

Sarcopenia is a significant muscular disorder characterized by a decline in muscle strength and muscle mass, which can lead to a loss of physical performance. Frailty, on the other hand, is a clinical condition arising from a reduction in physiological reserves, rendering an individual more vulnerable to stressors; it is associated with an increased risk of falls, functional dependence, hospitalization, and mortality. In patients undergoing chronic hemodialysis, common mechanisms-such as inflammation, oxidative stress, metabolic disturbances, malnutrition, and reduced physical activity-contribute to the development of both conditions. While previous studies have suggested that low selenium levels may be linked to a decline in muscle strength and mass, research simultaneously examining serum selenium levels in relation to both sarcopenia and frailty among chronic hemodialysis patients remains limited. This study aims to investigate the relationship between serum selenium levels and the presence of sarcopenia and frailty in patients receiving chronic hemodialysis, as well as to compare the clinical, laboratory, and physical performance characteristics of patients with and without selenium deficiency. It is anticipated that the findings will contribute to a better understanding of the factors associated with sarcopenia and frailty in this patient population and help evaluate the potential of serum selenium levels to serve as a biomarker.

02

Conditions studied

  • Frailty
  • Sarcopenia
  • Selenium

Keywords

  • frailty
  • sarcopenia
  • selenium
  • hemodialysis
03

In context

Frailty

1,233 studies on the registry are indexed under Frailty; 435 are open to participants now.

This study's enrollment of 78 is below the median of 211 across 503 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 439 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients over 18 years of age receiving hemodialysis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Receiving hemodialysis (HD) at least twice a week for a minimum of 3 months,
  • over 18 years of age,
  • agreeing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Presence of signs of an acute infection or inflammatory disease, a history of musculoskeletal trauma or neurological disorder,
  • use of selenium supplements,
  • presence of a malignancy,
  • visual impairment,
  • heart failure or the presence of a cardiac pacemaker,
  • a diagnosis of depression or psychosis,
  • use of medication [for these conditions],
  • a history of corticosteroid use
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
78 participants (actual)
Patient registry
No

Groups and cohorts

  • hemodialysis patients

    hemodialysis patients

    Other: FRAIL scale · Other: sarc-f · Other: time up go test · Other: hand grip strength

Interventions

  • OtherFRAIL scale

    frailty

  • Othersarc-f

    sarkopenia

  • Othertime up go test

    functional performance

  • Otherhand grip strength

    hand grip strength using hand dynamometer

06

What researchers measure

Primary outcomes

  1. frailty

    FRAIL scale: The FRAIL scale consists of 5 items, each scored on a scale of 0-1. The total score ranges from 0 to 5. Based on the total score, 0 is classified as robust/non-frail, 1-2 as prefrail, and 3 as frail.

    Time frame: 20 weeks

  2. sarcopenia sarc-f

    This is a questionnaire used for sarcopenia screening, which has been validated and tested for reliability in Turkish. Its components are defined as follows: Strength (S), Assistance with walking (A), Rising from a chair (R), Climbing stairs (C), and Falls (F). The questionnaire consists of 5 questions, each scored on a scale of 0-2 points. The recommended cut-off value for this scale is ≥4 points. A score of 4 or higher indicates a risk for sarcopenia.

    Time frame: 20 weeks

  3. time up go test

    Physical Performance: The "Timed Up and Go" (TUG) test was administered to assess the functional performance of the participants. The TUG test is a practical and rapidly applied assessment that measures walking speed, functional mobility, and dynamic balance. For the test, individuals were asked to sit on an armless chair with their feet touching the floor; upon the command "go," they were instructed to stand up, walk along a marked 3-meter path, turn around, and return to sit back down in the chair. During this process, the time taken by each individual to complete the activity was recorded.

    Time frame: 20 weeks

  4. hand grip strength

    Handgrip strength (HGS) was measured using a hydraulic hand dynamometer (Baseline). Measurements were performed three times on the hand without a fistula, and the highest value was recorded.

    Time frame: 20 weeks

  5. selenium

    Serum selenium concentrations were measured using inductively coupled plasma-mass spectrometry (ICP-MS) with an Agilent 7500 ICP-MS instrument (Agilent Technologies, USA), in accordance with the laboratory's analytical procedure (code: TIP-TÇT-52). Results were recorded in micrograms per liter (µg/L). Based on a previous study, a serum selenium level of \<70 µg/L was defined as selenium deficiency in our study.

    Time frame: 20 weeks

07

Study locations

1 site
  • Handan elif nur bayraktar
    Samsun, Samsun 55090, Turkey (Türkiye)
08

References and documents

Publications

  • Fujishima Y, Ohsawa M, Itai K, Kato K, Tanno K, Turin TC, Onoda T, Endo S, Okayama A, Fujioka T. Serum selenium levels are inversely associated with death risk among hemodialysis patients. Nephrol Dial Transplant. 2011 Oct;26(10):3331-8. doi: 10.1093/ndt/gfq859. Epub 2011 Mar 3. PubMed 21372251 ↗
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. PubMed 11253156 ↗
  • Nixon AC, Bampouras TM, Pendleton N, Woywodt A, Mitra S, Dhaygude A. Frailty and chronic kidney disease: current evidence and continuing uncertainties. Clin Kidney J. 2018 Apr;11(2):236-245. doi: 10.1093/ckj/sfx134. Epub 2017 Dec 2. PubMed 29644065 ↗
  • Giglio J, Kamimura MA, Lamarca F, Rodrigues J, Santin F, Avesani CM. Association of Sarcopenia With Nutritional Parameters, Quality of Life, Hospitalization, and Mortality Rates of Elderly Patients on Hemodialysis. J Ren Nutr. 2018 May;28(3):197-207. doi: 10.1053/j.jrn.2017.12.003. PubMed 29673501 ↗
  • Kooman JP, Kotanko P, Schols AM, Shiels PG, Stenvinkel P. Chronic kidney disease and premature ageing. Nat Rev Nephrol. 2014 Dec;10(12):732-42. doi: 10.1038/nrneph.2014.185. Epub 2014 Oct 7. PubMed 25287433 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896876
Responsible party
Handan Elif Nur BAYRAKTAR (specialist medical doctor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Oct 27, 2026
Start date
Feb 20, 2025
Primary completion
Jul 15, 2025
Completion
Jan 15, 2026
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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