Congenital HypothyroidismPhase 4CH-LT4NCT07754370
Levothyroxine Dosing in Neonatal Congenital Hypothyroidism
A Phase 4 study testing Levothyroxine in people with Congenital Hypothyroidism, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Congenital Hypothyroidism
- What is being tested?
- Levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2025to 20 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates diagnosed with primary congenital hypothyroidism.
- Full-term infants.
- Newly diagnosed.
- Treatment initiated during the neonatal period.
- Written informed parental consent.
Who cannot join
- Central congenital hypothyroidism.
- Prematurity.
- Major congenital malformations.
- Serious systemic illness affecting thyroid function.
- Previously thyroid hormone therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Optimizing Initial Levothyroxine Dosing in Neonates With 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.
- Conditions
- Congenital Hypothyroidism
- Being tested
- Levothyroxine
- Keywords
- Congenital hypothyroidism; Levothyroxine; Neonatal screening; Randomized controlled trial
- Medical subject headings
- Congenital Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
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.
LevothyroxineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| High-dose Levothyroxine Group | Experimental | Participants received initial levothyroxine therapy at a mean dose of 12.85 ± 1.12 µg/kg/day Receives: 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. Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start2 Nov 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HypothyroidismStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Neonates with primary congenital hypothyroidism were randomized in a 1:1 ratio to receive either a high-dose or moderate-dose of levothyroxine regmen
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Fathy El-Fiky, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754370
- Sponsor's protocol ID
- MENOUFIA-CH-LT4-RCT-001
- Acronym
- CH-LT4
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to ethical and privacy considerations related to neonatal participant data. Only aggregated study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Initial Levothyroxine Dosing in Neonates With Congenital Hypothyroidism
- ClinicalTrials.gov ID
- NCT07754370
- Acronym / sponsor ID
- CH-LT4 / MENOUFIA-CH-LT4-RCT-001
- Conditions
- Congenital Hypothyroidism
- Keywords
- Congenital hypothyroidism; Levothyroxine; Neonatal screening; Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Neonates with primary congenital hypothyroidism were randomized in a 1:1 ratio to receive either a high-dose or moderate-dose of levothyroxine regmen
| Arm | Type | Receives |
|---|---|---|
| High-dose Levothyroxine Group | Experimental | Drug: LevothyroxineParticipants received initial levothyroxine therapy at a mean dose of 12.85 ± 1.12 µg/kg/day |
| Moderate-dose Levothyroxine Group | Active comparator | Drug: LevothyroxineParticipants received initial levothyroxine therapy at a mean dose of 7.65 ± 0.56 µg/kg/day. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Neonates diagnosed with primary congenital hypothyroidism.
- Full-term infants.
- Newly diagnosed.
- Treatment initiated during the neonatal period.
- Written informed parental consent.
Key exclusion criteria (5 listed)
- Central congenital hypothyroidism.
- Prematurity.
- Major congenital malformations.
- Serious systemic illness affecting thyroid function.
- Previously thyroid hormone therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineHigh-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. | Drug | High-dose Levothyroxine Group |
| LevothyroxineModerate-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. | Drug | Moderate-dose Levothyroxine Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to ethical and privacy considerations related to neonatal participant data. Only aggregated study results will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine in people with Congenital Hypothyroidism, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of thyroid function after two weeks of treatment (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.