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Effect of fasting versus bedtime levothyroxin on primary hypothyroidism

Effect of fasting versus bedtime levothyroxin on primary hypothyroidism: A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201406299014N38
Enrollment
50
Registered
2014-07-04
Start date
2014-07-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

primary hypothyroidism. Hypothyroidism, unspecified

Interventions

Intervention 1: Oral levothyroxine 1.6 mcgr per kg before sleep for 8 weeks. Intervention 2: Oral levothyroxine 1.6 mcgr per kg half an hour before breakfast for 8 weeks.
Treatment - Drugs
Oral levothyroxine 1.6 mcgr per kg before sleep for 8 weeks
Oral levothyroxine 1.6 mcgr per kg half an hour before breakfast for 8 weeks

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) patients with primary hypothyroiditis; (b) age of 18 years or older. Exclusion criteria: (a) history of cardiovascular disease; (b) being pregnant or plan to pregnant; (c) history of malabsorption or gastritis; (d) using drug reducing levothyroxine absorption such as aluminum or sucralfate.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Response to treatment. Timepoint: 8 months after treatment. Method of measurement: based on serum T4 level.;Response to treatment. Timepoint: 8 months after treatment. Method of measurement: based on serum TSH level.

Secondary

MeasureTime frame
Probable systematic adverse effects such as nausea and vomiting. Timepoint: 8 months after treatment. Method of measurement: through history taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Bahareh Babeway

Farshchian Hospital

bahareh.babeway@gmail.com+98 81 3264 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026