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FrailtyNCT07896876

Selenium, Sarcopenia, and Frailty in Hemodialysis

An observational study of Frailty and Sarcopenia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Frailty, Sarcopenia, Selenium
What is being tested?
FRAIL scale, sarc-f and time up go test
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2025to 15 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients over 18 years of age receiving hemodialysis

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Handan elif nur bayraktar

    Samsun, Samsun, 55090

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Association Between Serum Selenium Levels and Sarcopenia and Frailty in Patients Receiving Maintenance Hemodialysis

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.

Being tested
FRAIL scale, sarc-f, time up go test, hand grip strength
Keywords
frailty, sarcopenia, selenium, hemodialysis
Medical subject headings
Frailty, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FRAIL scaleOther

    frailty

  • sarc-fOther

    sarkopenia

  • time up go testOther

    functional performance

  • hand grip strengthOther

    hand grip strength using hand dynamometer

Study groups in NCT07896876
Study groupRoleWhat they receive
hemodialysis patientshemodialysis patients
Receives: Other: FRAIL scale; Other: sarc-f; Other: time up go test; Other: hand grip strength

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start20 Feb 2025
  3. Primary completion15 Jul 2025
  4. Study completion15 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896876
Sponsor's protocol ID
Samsun-PMR-DRHENY-03
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Sarcopenia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

frailty (time frame: 20 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07896876, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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