A National Randomized Placebo-controlled Double-blind Multicenter Trial of LT4/LT3 Combination Therapy in Patients with Autoimmune Hypothyroidism: the T3-4-Hypo Trial.
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with overt or subclinical primary hypothyroidism 18 years or older.\*
• LT4 monotherapy for at least 6 months.
• LT4 monotherapy dose of 75-225 microg, with at least a dose of 1.2 microg/kg.
• TSH levels within the assay-specific reference ranges for at least 3 months.
• Severe tiredness with a large negative impact on daily life for at least 6 months, with or without other persisting complaints. This is based on the patient's own experience, without judgment of the treating physician.
• Sufficiently fluent in Dutch and able to read Dutch.
⁃ Thyroid peroxidase (TPO) and/or thyroglobulin (Tg) antibody positivity is not a requirement as these have frequently not been determined. Instead, we ensure that we only include patients with autoimmune hypothyroidism by excluding other causes of hypothyroidism (see exclusion criteria).
Locations
Other Locations
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
Amsterdam UMC - Location AMC
RECRUITING
Amsterdam
Gelre ziekenhuizen
NOT_YET_RECRUITING
Apeldoorn
Rijnstate
RECRUITING
Arnhem
Amphia ziekenhuis
RECRUITING
Breda
Van Weel-Bethesda Hospital
RECRUITING
Dirksland
Albert Schweitzer Hospital
RECRUITING
Dordrecht
Treant
NOT_YET_RECRUITING
Emmen
Admiraal de Ruyter Hospital
RECRUITING
Goes
University Medical Center Groningen
RECRUITING
Groningen
Saxenburgh MC
RECRUITING
Hardenberg
Radboudumc
RECRUITING
Nijmegen
Erasmus Medical Center
RECRUITING
Rotterdam
Maasstad Hospital
RECRUITING
Rotterdam
Franciscus Gasthuis & Vlietland
RECRUITING
Schiedam
Zuyderland
RECRUITING
Sittard
University Medical Center Utrecht
RECRUITING
Utrecht
Maxima Medical Center
RECRUITING
Veldhoven
Vie Curie MC
NOT_YET_RECRUITING
Venlo
Contact Information
Primary
Marco Medici, MD PhD
m.medici@erasmusmc.nl
+31107043415
Backup
Lizette Blankers, MD
l.blankers@erasmusmc.nl
+31636125982
Time Frame
Start Date:2022-10-07
Estimated Completion Date:2028-01
Participants
Target number of participants:600
Treatments
Active_comparator: LT4/LT3 combination therapy
The intervention group is treated with once daily a LT4 tablet and twice daily a LT3 tablet with a LT4:LT3 ratio 16:1.
Placebo_comparator: LT4/placebo therapy
The control group is treated with once daily a LT4 tablet and twice daily a placebo tablet.