|- candidate number||9223|
|- NTR Number||NTR2803|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2011|
|- Secondary IDs||NL35082.101.11 CCMO|
|- Public Title||Self controlled dose of Thyrax and QoL in patients with hypothyroidism.|
|- Scientific Title||The effect of a self controlled dose of Levothyroxine on the quality of life and thyroid stimulating hormone in patients treated for hypothyroidism: A randomized, double blind, consecutive study.|
|- ACRONYM||Patients in control of Thyrax|
|- hypothesis||Hypothyroidism is a chronical disease with a bad influence on quality of life in this patients. Some researchers mean that self control in treatment and medication is a potential good development that can improve medical condition, make patients stronger and can positively influence attitude and behaviour. Our hypothesis is that when patients can have influence on their dose of Levothyroxine, this will have a positive influence on their quality of life. It is also interesting what the role of placebo effect in this situation will be. |
|- Healt Condition(s) or Problem(s) studied||Quality of life, Hypothyroidism , Levothyroxine, Self-controlled dose|
|- Inclusion criteria||1. Primary Hypothyroidism;|
3. Stable dose of Levothyroxine for over 6 months;
4. Age 18-75;
5. Own wish to change dose of medication.
|- Exclusion criteria||Pregnancy.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2011|
|- planned closingdate||1-jun-2013|
|- Target number of participants||100|
|- Interventions||Patients who are not content about the treatment of their hypothyroidism with Levothyroxine get the chance to controle their own dose. There will be 2 moments during the study where they can decide if they want to raise their dose of Levothyroxine. At the first time of choice randomization will follow and the first half of the group will get 25 mcg extra Levothyroxine and the other half will receive a placebo. After 6 weeks of treatment the placebo group will also receive 25 mcg extra medication. So after 12 weeks the whole group has been treated with 25 mcg extra Levohyroxine. At the second moment of choice patients can either go back to their original dose, stay at 25 mcg extra or decide they want another 25 mcg extra. There will be another randomization in group that wants extra medication. Half will get extra 25 mcg extra and half will get an placebo. |
|- Primary outcome||1. QoL by SF/RAND 36;|
2. Symptoms and complaints by symptomlist hypothyroidism;
3. General symptom list and Hospital anxiety and depression scale;
4. TSH,T4 and T3.
|- Secondary outcome||1. Influence of BMI on QoL;|
2. Clinical parameters like heartbeat, blood pressure and laboratory findings.
|- Timepoints||T = 0, 6, 12 and 18 months.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. C. Zevenbergen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. C. Zevenbergen|
|- Sponsor/Initiator ||Maasstad Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background of the study:|
Hypothyroidism is a chronical disease with a bad influence on quality of life in this patients. Some researchers mean that self control in treatment and medication is a potential good development that can improve medical condition, make patients stronger and can positively influence attitude and behaviour. Our hypothesis is that when patients can have influence on their dose of Levothyroxine, this will have a positive influence on their quality of life. It is also interesting what the role of placebo effect in this situation will be.
Objective of the study:
The goal of this study is to positively influence quality of life in patients with hypothyroidism by giving them back control in their treatment. We also want to see what the placebo effect will be. And at last we want to check if patients have the urge to lower their TSH levels if they can choose their own dose of Levothyroxine and if that has a relationship with their quality of life.
A randomized, double blind, consecutive study on the outpatient clinic at the department of internal medicine and endocrinology of the Maasstad Hospital Rotterdam. Patients treated with Levothyroxine because of primary hypothyroidism will be included.
Patients who visit the outpatient clinic of the department of internal medicine because of primary hypothyreoidism. There will have to be a state of euthyroidim and they have to use a stable dose of Levothyroxine for over more than 6 months without side effects.
|- Main changes (audit trail)|
|- RECORD||11-mrt-2011 - 11-apr-2011|