Effect of Synthetic LT4/L-T3 combination therapy versus desiccated animal thyroid extract?
- Conditions
- HypothyroidismMedDRA version: 20.0Level: LLTClassification code 10045920Term: Unspecified hypothyroidismSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2019-000239-21-DK
- Lead Sponsor
- Birte Nygaard, Dept of Endocrinology, Herelv Hosptial, University og Copenhagen,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Hypothyroidism, defined as s-TSH>4,8mU/l measured at least twice, before initial therapy is given.
• Stabile s-TSH within normal reference range for a minimum of 6 month and still having persistent symptoms similar to hypothyroidism, with no other explanation for these symptoms.
• Due to the persistent symptoms treated with L-T4/L-T3 combination therapy in a ration similar to human levels app. 1:17
• Having effect on QoL and hypothyroid symptom persisting for a minimum of 12 month
• S- TSH levels 0,1- 4,8mU/l
This group is chosen to reach the selected group of patients with a possible need supplementary therapy than l-T4 – in which other explanations of the symptoms have been ruled out.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Previous thyroid cancer
Previous hyperthyroidism
Postpartum thyroiditis not having a period of reduction/ discontinuing T4 therapy
Pregnant or plan for being pregnant within the next year
Reduced Danish skills
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this project is to characteristic the subset of patients, not responding to L-T4 therapy and to compare combination LT4+LT3 therapy to therapy with DTE to determine if a difference is present between these therapies evaluated by effect as well as side effect. Hereby, we can bring new evidence, and if an effect of DTE are superior to L-T4/L-T3 therapy and without increased risks of side effect advocate for the introduction of this therapy in Danish and international guidelines and increase the options individualized therapy for hypothyroidism.;Secondary Objective: not applicaple;Primary end point(s): Preference of DTE vs L-T4/L-T3 combination therapy;Timepoint(s) of evaluation of this end point: end of study - 8 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Quality of Life (QoL) evaluated by a thyroid specific QoL questionnaire (Thy-PRO), changes in thyroid function parameters (TSH, total and free T4 and T3), lipid and diabetes status and body composition (lean mass, fat mass). <br>Heart rate (integrated and arrhythmias (evaluated by 24 hours continuedly monitoring at home (Holter monitoring) , Changes in bone metabolism markers (PINP,CTX) calcium metabolism and bone mineral density;Timepoint(s) of evaluation of this end point: Qol will be evaluated every 4 week<br><br>Otherwise parameters will be measured before and after each treatment period