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Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial

Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial - Evening versus morning administration levothyroxine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30653
Enrollment
100
Registered
2007-02-28
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism slow thyroid

Interventions

During the study, patients will have to take 2 tablets a day (one in the morning and one at bedtime), instead of 1 tablet. During these 16 weeks they will return to the outpatient department five ti

Sponsors

Medisch Centrum Rijnmond-Zuid
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 years At least 6 months on a stable regimen of levothyroxine, with TSH 0.4-4.0 mU/l

Exclusion criteria

Exclusion criteria: Pregnancy Disease of the stomach, jejunum or ileum Use of medication known to interfer with the uptake of levothyroxine

Design outcomes

Primary

MeasureTime frame
Primary endpoint will be a significant change in TSH and thyroid hormones FT4/T3 with a switch to the bedtime administration of levothyroxine compared to the morning administration.

Secondary

MeasureTime frame
Secundary endpoints will be a change in blood pressure, pulse, weight, other lab results (ferritin, albumin, lipids etc.), a change in quality of life and symptoms of hypo-or hyperthyroidism. Furthermore we will study if patients that were subclinically hypothyroid, and become euthyroid or (subclinically) hyperthyroid because of the different administration time of levothyroxine, have a change in quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)