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Home » Trials » SLCTR/2018/007

Efficacy and safety of once weekly thyroxine versus daily thyroxine as maintenance therapy of hypothyroidism; a randomized controlled exploratory clinical trial

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SLCTR Registration Number

SLCTR/2018/007

Date of Registration

09 Feb 2018

The date of last modification

Jan 13, 2022

Trial Status


Application Summary

Scientific Title of Trial

Efficacy and safety of once weekly thyroxine versus daily thyroxine as maintenance therapy of hypothyroidism; a randomized controlled exploratory clinical trial

Public Title of Trial

Efficacy and safety of once weekly thyroxine versus daily thyroxine as maintenance therapy of hypothyroidism; a randomized controlled exploratory clinical trial

Disease or Health Condition(s) Studied

Hypothyroidism

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1202-3740

Any other number(s) assigned to the trial and issuing authority

67/17 (ERC: Sri Jayewardenepura)


Trial Details

What is the research question being addressed?

What is the efficacy, safety and acceptability of once weekly dosing of thyroxine compared to daily dosing of thyroxine as maintenance therapy for hypothyroidism?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2

Intervention(s) planned

Study setting: Endocrine clinic, Colombo South Teaching Hospital, Sri Lanka

Method of allocation: Simple randomization using a pre-planned computer generated random table. Random table will be kept with an investigator not involved in patient recruitment and randomization of each patient will be done via telephone to maintain allocation concealment.

Intervention group: participants will receive oral thyroxine once weekly in a dose 7 times the individual’s usual daily maintenance dose beginning on day 1 of the trial, with no thyroxine given on days in between. Duration of treatment : 12 weeks

Control group: participants will continue to take thyroxine daily in the individual’s usual daily maintenance dose. Trial medications will be provided to the patients by the investigators and all trial patients will receive the same brand of thyroxine. Duration of treatment : 12 weeks

Participants and healthcare providers will not be blinded; Outcome assessors and data analysts will be blinded to the intervention status of the participants.

Inclusion criteria

  1. Age >18 years and <70 years
  2. Primary hypothyroidism due to autoimmune hypothyroidism, thyroidectomy or radioiodine treatment
  3. Serum Thyroid-Stimulating Hormone (TSH) and free thyroxine (T4) are within normal range
  4. No change in thyroxine dose in the past 3 months
  5. Baseline blood pressure <140/90 mmHg
  6. Baseline pulse rate <90 bpm
  7. Adequate contraceptive measures for women of childbearing age
  8. Meaningful consent is available

Exclusion criteria

  1. Ischaemic heart disease (previous acute coronary syndrome, stable angina, coronary artery revascularization or evidence of cardiac ischaemia on ECG, exercise ECG or echocardiography)
  2. Pre-existing heart failure or ejection fraction <50% on echocardiography
  3. History of cardiac arrhythmia
  4. Uncontrolled hypertension (BP >140/90 mmHg)
  5. Renal failure with eGFR <45 ml/min/1.73m2
  6. Pre-existing chronic liver disease or liver transaminases >5 times upper limit of normal reference range
  7. Bone fracture in past 3 months
  8. Paget’s disease of bone
  9. Malabsorption
  10. Pregnancy
  11. History of thyroid malignancy
  12. Any terminal disease (eg. advanced heart failure, advanced respiratory disease, malignancy)
  13. Not available for follow-up (e.g. no fixed address, unable to come for regular clinic follow-ups)
  14. Participation in another clinical trial within 3 months

Primary outcome(s)

1.
  1. Proportion of patients maintained in euthyroid state
  2. Mean TSH and free T4
  3. Mean end-systolic diameter, end diastolic diameter and ejection fraction on echocardiogram
  4. Mean Hyperthyroid Symptom Score (Klein et al, 1988)
 [

  1. End of the study period of 12 weeks

  2. At the end of the study period of 12 weeks

  3. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen.

  4. 4 - 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen

]

Secondary outcome(s)

1.
  1. Mean blood pressure
  2. Mean heart rate
  3. Incidence of cardiac complications (composite of tachyarrhythmias, stable angina, acute coronary syndromes, heart failure)
  4. Incidence of biochemically confirmed thyrotoxicosis
  5. Mean visual analogue Arizona Integrative Outcomes Scale (AIOS) score to assess patient well-being
[

  1. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen

  2. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen

  3. During the study period of 12 weeks.

  4. During the study period of 12 weeks

  5. 4 – 6 hours after first dose of thyroxine and 12 weeks after being on the prescribed regimen

]

Target number/sample size

100 (50 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2018-05-01

Anticipated end date

2020-01-01

Date of first enrollment

2018-07-17

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

None (Investigator funded)

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2017-11-27

Approval number

67/17

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
Institutional Address:Gangodawila, Nugegoda Sri Lanka
Telephone:+94-112758000 (Extension: 4075)
Email: erc.fms.usjp@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. D.U.S Bulugahapitiya
Consultant Endocrinologist
Diabetes and Endocrine Unit, Colombo South Teaching Hospital, Kalubowila, Sri Lanka.

Mob: 0777356105

udithakaush@googlemail.com

Contact Person for Public Queries

Dr. D.U.S Bulugahapitiya
Consultant Endocrinologist
Diabetes and Endocrine Unit, Colombo South Teaching Hospital, Kalubowila, Sri Lanka.

Mob: 0777356105

udithakaush@googlemail.com

Primary study sponsor/organization

Dr. D.U.S Bulugahapitiya
Consultant Endocrinologist
Diabetes and Endocrine Unit, Colombo South Teaching Hospital, Kalubowila, Sri Lanka.
Mob: 0777356105

udithakaush@googlemail.com

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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