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Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)

7. Oktober 2015 aktualisiert von: Newcastle-upon-Tyne Hospitals NHS Trust

Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) SORTED 1 - a Randomised Controlled Trial (Pilot Study), SORTED 2 - Qualitative Interviews, SORTED 3 - Retrospective Cohort

All patients with hypothyroidism are currently treated the same way, regardless of age. The investigators want to look at whether people aged 80 years or older would benefit from being treated with lower doses of levothyroxine. There are three reasons why the investigators think this could be beneficial, but this is not yet proven:

  1. Some older people with hypothyroidism may have few symptoms.
  2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood to decide the dose of Thyroxine received. The standard "normal" TSH range used to determine the dose of levothyroxine is from younger people. The investigators wonder whether this is appropriate to all age ranges particularly as the investigators know that older people may normally have higher TSH values.
  3. If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heartbeat.

The best way to test whether older people benefit from lower doses of levothyroxine is by a large clinical trial. Before the investigators can do this, the investigators need to run a smaller clinical trial called a "pilot study" (SORTED 1) to examine whether this is practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or above.

Participants will be randomly allocated to receive their routine or lower dose of levothyroxine. Follow-up will be conducted over approximately 25 weeks.

The investigators also propose a qualitative study (SORTED 2) to specifically understand patient's willingness to take part in a RCT and participant's experience of the intervention.

Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of studying outcomes after 4 years. The cohort study will collect data required to inform a sample size calculation for a future full study where the primary outcome will be 4 year mortality.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

48

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigtes Königreich
    • Tyne and Wear
      • Gateshead, Tyne and Wear, Vereinigtes Königreich, NE8 4YL
        • Bensham Hospital
      • Newcastle upon Tyne, Tyne and Wear, Vereinigtes Königreich, NE1 4LP
        • Clinical Research Facility

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

80 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Males and Females aged 80 years or older
  • Diagnosed with hypothyroidism and treated with Levothyroxine for at least 6 months
  • Living independently in the community
  • All TSH results within the range 0.4 - 4mU/L in the 3 months before commencing the study
  • Participant has provided written informed consent for participation in the study, prior to any study-specific procedures

Exclusion Criteria:

  • Established dementia and therefore deemed incapable of providing informed consent.
  • Other medical conditions which, inthe opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound)
  • Nursing Homes or Residential Care Home residents
  • Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH
  • Individuals on 25 mcg dailty of LT4: dose reduction will mean that they stop thyroid replacement treatment
  • Non english speaking individuals
  • Participation in any other investigational trials within the last 3 months
  • Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil)
  • Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Lower dose of levothyroxine
Participants may be randomised to receive a lower dose of levothyroxine (lower than their usual dose) to achieve a target TSH level of 4.1 - 8.0 mU/L
Arzneimittel: Levothyroxine
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Arzneimittel: Levothyroxine
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
Sonstiges: Standard dose of levothyroxine
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
Arzneimittel: Levothyroxine
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Arzneimittel: Levothyroxine
Participants in the standard dose of treatment will receive their usual dose of levothyroxine

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant's acceptability of study design and willingness to enter study
Zeitfenster: Until completion of recruitment, approximately 24 months
Participant's acceptability of study design as measured byt he completion rate of participants in each randomised group, as well as their willingness to enter the trial (consented participant to eligible participant approached ratio)
Until completion of recruitment, approximately 24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant recruitment rate
Zeitfenster: Until completion of recruitment, approximately 24 months
As measured by the number of patients randomised divided by the length of the recruitment period. The recruitment period runs from the date that recruitment opened to the date of last randomisation.
Until completion of recruitment, approximately 24 months
Time to achieve desired TSH levels
Zeitfenster: Until participant completion of SORTED 1 study, approximately within 24 weeks
To review and assess the dose titration strategy (ie reduced LT4 dose or same dose LT4) and length of time required to achieved desired TSH levels (ie number of participants in each group that reach target TSH range at both 12 and 24 weeks)
Until participant completion of SORTED 1 study, approximately within 24 weeks
Medication compliance
Zeitfenster: For the duration of participant involvment in the study, maximum of 25 weeks
Tablet count
For the duration of participant involvment in the study, maximum of 25 weeks
The acceptability of three patient completed questionnaires
Zeitfenster: For the duration of participant involvement in the study, maximum of 25 weeks
The questionnaires include the generic QoL questionnaire (EQ-5D), validated disease-specific QoL questionanaire (ThyDQol) and disease specific hypothyroid-symptom check list (ThySC). The time taken to complete the three questionnaires will be recorded and questionnaire completion rates will be recorded and usefulnesss of questionnaires determined. Any third-party held required in a questionnaire's completion will be recorded.
For the duration of participant involvement in the study, maximum of 25 weeks
Assessment of mobility
Zeitfenster: For the duration of participant involvement in this study, maximum of 25 weeks
Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
For the duration of participant involvement in this study, maximum of 25 weeks
Change in specific cardiovascular risk factors
Zeitfenster: For the duration of participant involvement in the study, maximum of 25 weeks
Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
For the duration of participant involvement in the study, maximum of 25 weeks
Measure of risk of falls
Zeitfenster: For the duration of participant involvement in the study, maximum 25 weeks
Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
For the duration of participant involvement in the study, maximum 25 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Mitarbeiter

National Institute for Health Research, United Kingdom

Ermittler

  • Hauptermittler: Salman Razvi, Gateshead Health NHS Foundation Trust

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2012

Primärer Abschluss (Tatsächlich)

1. August 2014

Studienabschluss (Tatsächlich)

1. August 2014

Studienanmeldedaten

Zuerst eingereicht

16. Juli 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juli 2012

Zuerst gepostet (Schätzen)

24. Juli 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Oktober 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Oktober 2015

Zuletzt verifiziert

1. Oktober 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 5863 (Andere Kennung: Project ID - Ethical Committee UZA)
  • PB-PG-0610-22139 (Andere Zuschuss-/Finanzierungsnummer: National Institute for Health Research Research for patient Benefit)
  • 2011-004425-27 (EudraCT-Nummer)
  • ISRCTN16043724 (Registrierungskennung: ISRCTN)

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