A Phase 4 interventional study of Levothyroxine and Levothyroxine in Congenital Hypothyroidism, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Menoufia University · Phase 4, Interventional, and Treatment
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.
27 studies on the registry are indexed under Congenital Hypothyroidism; 9 are open to participants now.
Browse Congenital Hypothyroidism studies →Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.
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Participants received initial levothyroxine therapy at a mean dose of 12.85 ± 1.12 µg/kg/day
Drug: Levothyroxine
Participants received initial levothyroxine therapy at a mean dose of 7.65 ± 0.56 µg/kg/day.
Drug: Levothyroxine
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.
Moderate-dose Levothyroxine Group (Active Comparator) Oral levothyroxine sodium was initiated immediately after diagnosis of primary congenital hypothyroidism at a moderate initial dose of approximately 7-9 µg/kg/day (mean initial dose: 7.65 ± 0.56 µg/kg/day). The dose was subsequently adjusted according to serial thyroid function tests (TSH and free T4 levels) during follow-up.
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.
Time frame: Two weeks
Plan to share: No — IPD will not be shared due to ethical and privacy considerations related to neonatal participant data. Only aggregated study results will be reported.
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Jul 2026, 8 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thyroxine