''Hypothyroidism'' or ''underactive thyroid''
Conditions
Interventions
Participants of the intervention group have to take their LT4 with breakfast
after a minimum dose increase of LT4 (*the breakfast group*), while
participants of the control group have to take their
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint will be the percentage of participants in whom two, consecutive predefined stable TSH levels will be reached when LT4 is ingested with breakfast after LT4 dose adjustments (*the breakfast group*). This will be compared with the number of participants which reach two, consecutive stable TSH levels when LT4 is ingested at least 30 minutes before breakfast (*the fasting group*). A *stable* TSH level will be defined as a maximum deviation of plus or minus 1 mIU/L compared to the TSH level at baseline of that specific participant. Any notable differences between different levothyroxine brands will be tracked. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints will be percentages of reported yes or no answers to the questions *Are you feeling better today compared to twelve weeks ago?* and 'Do you or would you prefer LT4 intake with breakfast?'. We would like to investigate whether a self-reported well-being is associated with participant*s TSH levels and whether it is associated with taking LT4 with or without breakfast. Besides that, another secondary study endpoint will be the number of participants of the breakfast group that were able to continue LT4 intake with breakfast after a follow-up period of six and twelve months. Furthermore, changes in body weight, glucose and lipid levels will be collected for future research purposes to investigate the effect of LT4 intake with breakfast on metabolic factors since patients with hypothyroidism have a higher prevalence of metabolic syndrome including dyslipidaemia, diabetes and obesity. | — |
Countries
Netherlands
Outcome results
None listed