Postponing breakfast in patients using levothyroxine: old-fashioned?
- Conditions
- ''Hypothyroidism'' or ''underactive thyroid''10043739
- Registration Number
- NL-OMON53296
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 86
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- age of 18 years or older.
- (subclinical) hypothyroidism of any underlying cause (except the diagnoses
mentioned in exclusion criteria) including hypothyroidism after thyroid surgery
because of low risk thyroid carcinoma.
- receive current treatment with levothyroxine (LT4) in a dose of at least 1.0
mcg/kg.
- use breakfast on >5 days per week.
- is able to give written informed consent.
- masters a language in which sufficient communication can take place with the
members of the research team.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- immune-therapy mediated hypothyroidism.
- central hypothyroidism.
- high risk thyroid carcinoma.
- being pregnant or having a wish to become pregnant during the study period.
- having serious or debilitating chronic diseases (such as serious cardiac,
pulmonary, gastrointestinal and chronic renal disorders (dialysis) or
malignancy) according to the investigator*s opinion.
- having active malabsorptive diseases (such as celiac disease, inflammatory
bowel disease, chronic pancreatitis or intestinal bypass surgery) according to
the investigator*s opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint will be the percentage of participants in whom two,<br /><br>consecutive predefined stable TSH levels will be reached when LT4 is ingested<br /><br>with breakfast after LT4 dose adjustments (*the breakfast group*). This will be<br /><br>compared with the number of participants which reach two, consecutive stable<br /><br>TSH levels when LT4 is ingested at least 30 minutes before breakfast (*the<br /><br>fasting group*). A *stable* TSH level will be defined as a maximum deviation of<br /><br>plus or minus 1 mIU/L compared to the TSH level at baseline of that specific<br /><br>participant. Any notable differences between different levothyroxine brands<br /><br>will be tracked.</p><br>
- Secondary Outcome Measures
Name Time Method