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Completed

NCT Number: NCT07754370

Levothyroxine Dosing in Neonatal Congenital Hypothyroidism

This randomized controlled trial compared high-dose and moderate-dose levothyroxine as initial therapy for neonates with primary congenital hypothyroidism. One hundred one infants were randomized to receive either approximately 12.85 or 7.65 µg/kg/day. Thyroid function and dose adjustments were assessed every 2 weeks over the first six weeks of treatment to evaluate efficacy and safety.

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Key information

Conditions

Congenital Hypothyroidism Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Hypothyroidism Musculoskeletal Diseases Thyroid Diseases

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonates diagnosed with primary congenital hypothyroidism.
  • Full-term infants.
  • Newly diagnosed.
  • Treatment initiated during the neonatal period.
  • Written informed parental consent.

Exclusion criteria

  • Central congenital hypothyroidism.
  • Prematurity.
  • Major congenital malformations.
  • Serious systemic illness affecting thyroid function.
  • Previously thyroid hormone therapy.

Treatment and study plan

Levothyroxine

Drug

High-dose Levothyroxine Group (Experimental Arm)

Intervention Description:

Oral levothyroxine sodium was initiated immediately after diagnosis of primary congenital hypothyroidism at a high initial dose of approximately 10-15 µg/kg/day (mean initial dose: 12.85 ± 1.12 µg/kg/day). The dose was subsequently adjusted according to serial thyroid function tests (TSH and free T4 levels) during follow-up.

Primary outcomes

  1. Normalization of thyroid function after two weeks of treatment

    Time frame: Two weeks

    Comparison of serum TSH and free T4 between treatment groups after two weeks of levothyroxine therapy.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Optimizing Initial Levothyroxine Dosing in Neonates With Congenital Hypothyroidism

Acronym: CH-LT4

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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