Actively Recruiting
LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients with Autoimmune Hypothyroidism.
Led by M. Medici · Updated on 2025-02-26
600
Participants Needed
19
Research Sites
273 weeks
Total Duration
On this page
Sponsors
M
M. Medici
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hypothyroidism is common, affecting 5% of the general population, for which levothyroxine (LT4) monotherapy is the standard treatment. Despite normalized serum thyroid hormone levels, 10-15% of LT4 treated patients have various persistent complaints, the most important of which is tiredness. This could be explained by the fact that physiological T4/T3 ratios cannot be reached with LT4 monotherapy, as in a healthy individual T3 is not only derived from T4/T3 conversion but is also directly produced by the thyroid itself. Studies have reported contradicting results as to whether addition of liothyronine (LT4/LT3 combination therapy) in patients with persistent tiredness on LT4 monotherapy is effective or not. Studies have suggested higher effectiveness in patients carrying genetic variation in the type 2 deiodinase (DIO2-rs225014) and monocarboxylate transporter 10 (MCT10-rs17606253) genes. Objective: To investigate whether addition of liothyronine (LT4/LT3 combination therapy) in in patients with persistent tiredness on LT4 monotherapy is effective or not in relieving tiredness.
CONDITIONS
Official Title
LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients with Autoimmune Hypothyroidism.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with overt or subclinical primary hypothyroidism aged 18 years or older
- LT4 monotherapy for at least 6 months
- LT4 dose between 75-225 micrograms, with at least 1.2 micrograms per kilogram
- TSH levels within the normal assay-specific range for at least 3 months
- Severe tiredness greatly impacting daily life for at least 6 months, based on patient's own experience
- Sufficient fluency in Dutch and ability to read Dutch
You will not qualify if you...
- Congenital hypothyroidism, hypothyroidism after (sub)acute thyroiditis, or secondary (central) hypothyroidism
- History of thyroid surgery, radioactive iodine treatment, or head/neck radiotherapy
- Current or past use of thyroid interfering drugs such as amiodarone, immunotherapy, tyrosine kinase inhibitors, interferon, lithium, or current corticosteroids or dopamine
- Current psychiatric disease treated at a specialized mental health institution (gespecialiseerde GGZ)
- Clinical diagnosis of dementia
- Pregnancy, breastfeeding, or planning pregnancy within 2 years
- Women of reproductive age not using adequate contraception, not sterilized, and without a sterilized partner
- Significant functional or structural heart abnormalities
- Recent acute coronary syndrome or unstable angina within 4 weeks
- Current or past atrial fibrillation
- ECG conduction disorders (QRS >120 ms or prolonged QTc: women ≥460 ms, men ≥450 ms)
- Frequent ventricular extrasystole or ventricular tachycardia
- Other clear medical causes for tiredness such as end-stage renal disease, anemia, severe COPD, cancer
- Major life events causing tiredness like mourning or job loss
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Flevoziekenhuis
Almere Stad, Netherlands
Actively Recruiting
2
Amsterdam UMC - Location AMC
Amsterdam, Netherlands
Actively Recruiting
3
Gelre ziekenhuizen
Apeldoorn, Netherlands
Not Yet Recruiting
4
Rijnstate
Arnhem, Netherlands
Actively Recruiting
5
Amphia ziekenhuis
Breda, Netherlands
Actively Recruiting
6
Van Weel-Bethesda Hospital
Dirksland, Netherlands
Actively Recruiting
7
Albert Schweitzer Hospital
Dordrecht, Netherlands
Actively Recruiting
8
Treant
Emmen, Netherlands
Not Yet Recruiting
9
Admiraal de Ruyter Hospital
Goes, Netherlands
Actively Recruiting
10
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
11
Saxenburgh MC
Hardenberg, Netherlands
Actively Recruiting
12
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
13
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
14
Maasstad Hospital
Rotterdam, Netherlands
Actively Recruiting
15
Franciscus Gasthuis & Vlietland
Schiedam, Netherlands
Actively Recruiting
16
Zuyderland
Sittard, Netherlands
Actively Recruiting
17
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
18
Maxima Medical Center
Veldhoven, Netherlands
Actively Recruiting
19
Vie Curie MC
Venlo, Netherlands
Not Yet Recruiting
Research Team
M
Marco Medici, MD PhD
CONTACT
L
Lizette Blankers, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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