NCT07210450CompletedPhase 2/3
Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia
The Effect of Glutamine on Reducing Pulmonary Arterial Pressure in Non-transfusion-dependent Thalassemia Patients: a Single Blind Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 Oct 2025
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether L-glutamine can help lower pulmonary artery pressure in adults with non-transfusion-dependent thalassemia (NTDT). The main questions it aims to answer are: Does L-glutamine reduce pulmonary artery pressure after 60 days of treatment? Is the effect of L-glutamine different from standard care alone? Researchers will compare two groups: Intervention group: Participants receive oral L-glutamine in addition to their standard treatment. Control group: Participants continue with standard treatment only. Participants will: Take either L-glutamine (by mouth) or standard care for 60 days. Undergo echocardiography at the beginning and end of the study to measure pulmonary artery pressure. Attend follow-up visits to monitor safety, adherence, and possible side effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 29 Sept 2025
- Start date
- 15 Aug 2023
- Primary completion date
- 22 May 2025
- Lead sponsor
- Mazandaran University of Medical Sciences
- Diseases
- Thalassaemia
- NCT number
- NCT07210450
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 8
- From 15 Aug 2023 to the primary completion date, 22 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to L-glutamine.
- History of other cardiac diseases associated with pulmonary hypertension (per investigator assessment).
Lab values
- Hepatic dysfunction: ALT \>3× upper limit of normal.
- Renal dysfunction: serum creatinine \>2× upper limit of normal.
Age
- Age \<18 years.
Other
- Refusal or inability to provide informed consent.
- Pregnancy or breastfeeding.
- Use of amino-acid/protein supplements within the past 3 months.
Who the study is looking for
- Adults (≥18 years), any sex.
- Diagnosis of non-transfusion-dependent β-thalassemia (NTDT).
- Pulmonary artery pressure (PAP) \> 35 mmHg estimated by Doppler echocardiography at screening.
- Able and willing to provide written informed consent.
- On a stable standard-of-care regimen (e.g., chelation and/or hydroxyurea) per treating physician judgment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bu Ali Sina Hospital Coordinator of this site? Confirm its status | Sari | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.