Effect of Anticonvulsant Drugs on Thyroid Hormones in Children with Epilepsy

Investigating the Effect of Four Anticonvulsant Drugs (Clobazam, Phenobarbital, Carbamazepine, Levetiracetam) on TSH, Free T4, and T3 Hormone Levels in Children Aged 2 to 16 Years

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250622066215N1

Enrollment

Registered

2025-10-28

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Condition 1: Epilepsy. Condition 2: Drug-induced thyroid disorders. Epilepsy and recurrent seizures Hypothyroidism due to medicaments and other exogenous substances

Interventions

Intervention 1: Intervention group 1: Clobazam administered orally at standard dose based on child body weight and seizure type according to standard epilepsy treatment protocol. Starting dose is usua

Eligibility

Sex/Gender

All

Age

2 Years to 16 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 16 years diagnosed with epilepsy Candidates for monotherapy treatment with one of the four anticonvulsant drugs No history of thyroid disorders No developmental disorders Written informed consent from parents or legal guardians

Exclusion criteria

Exclusion criteria: Need for multiple anticonvulsant drug therapy History of head trauma or neurosurgical procedures Chronic kidney disease Metabolic disorders Need for additional drug doses at any time during the study

Design outcomes

Primary

Measure	Time frame
Changes in serum thyroid stimulating hormone levels. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of thyroid stimulating hormone level from venous blood sample by immunoassay method with unit of milli international units per liter at Bouali Hospital laboratory.;Changes in serum free thyroxine levels. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of free thyroxine level from venous blood sample by immunoassay method with unit of picograms per deciliter at Bouali Hospital laboratory.;Changes in serum triiodothyronine levels. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of triiodothyronine level from venous blood sample by immunoassay method with unit of nanograms per deciliter at Bouali Hospital laboratory.;Changes in body weight. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of body weight using digital scale with unit of kilograms.;Changes in body mass index. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Calculation of body mass index by dividing weight by height squared with unit of kilograms per square meter.	—

Measure

Time frame

Changes in serum thyroid stimulating hormone levels. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of thyroid stimulating hormone level from venous blood sample by immunoassay method with unit of milli international units per liter at Bouali Hospital laboratory.;Changes in serum free thyroxine levels. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of free thyroxine level from venous blood sample by immunoassay method with unit of picograms per deciliter at Bouali Hospital laboratory.;Changes in serum triiodothyronine levels. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of triiodothyronine level from venous blood sample by immunoassay method with unit of nanograms per deciliter at Bouali Hospital laboratory.;Changes in body weight. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Measurement of body weight using digital scale with unit of kilograms.;Changes in body mass index. Timepoint: At baseline (before starting anticonvulsant treatment) and 6 months after treatment initiation. Method of measurement: Calculation of body mass index by dividing weight by height squared with unit of kilograms per square meter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactElika Eqlimi

Ardabil University of Medical Sciences

elika.eqlimi@gmail.com+98 912 538 4397

Outcome results

None listed

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