Levothyroxine Dosing in Neonatal Congenital Hypothyroidism

NCT07754370 | Completed Phase 4

• 1 other identifier: MENOUFIA-CH-LT4-RCT-001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Hypothyroidism

Keywords

Congenital hypothyroidism; Levothyroxine; Neonatal screening; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Normalization of thyroid function after two weeks of treatment

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

  Two weeks

Study Arms (2)

High-dose Levothyroxine Group

EXPERIMENTAL

Participants received initial levothyroxine therapy at a mean dose of 12.85 ± 1.12 µg/kg/day

Drug: Levothyroxine

Moderate-dose Levothyroxine Group

ACTIVE COMPARATOR

Participants received initial levothyroxine therapy at a mean dose of 7.65 ± 0.56 µg/kg/day.

Drug: Levothyroxine

Interventions

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.

High-dose Levothyroxine Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Congenital Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatrics

Model Details: Neonates with primary congenital hypothyroidism were randomized in a 1:1 ratio to receive either a high-dose or moderate-dose of levothyroxine regmen

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: November 2, 2025
• Primary Completion: July 20, 2026
• Study Completion: July 20, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)