Pulmonary Artery PressurePhase 2/3NCT07210450
Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia
A Phase 2/3 study testing L-glutamine in people with Pulmonary Artery Pressure and Thalassemia, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Artery Pressure, Thalassemia, Non-transfusion Dependent Thalassemia
- What is being tested?
- L-glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIran
- Study dates
- 15 Aug 2023to 27 Sep 2025
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18 years.
- Refusal or inability to provide informed consent.
- Hepatic dysfunction: ALT >3× upper limit of normal.
- Renal dysfunction: serum creatinine >2× upper limit of normal.
- Known hypersensitivity to L-glutamine.
- Pregnancy or breastfeeding.
- Use of amino-acid/protein supplements within the past 3 months.
- History of other cardiac diseases associated with pulmonary hypertension (per investigator assessment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Glutamine on Reducing Pulmonary Arterial Pressure in Non-transfusion-dependent Thalassemia Patients: a Single Blind Randomized Clinical Trial
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:
Read more
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.
- Being tested
- L-glutamine
- Keywords
- L-glutamine, Non-transfusion Dependent Thalassemia, pulmonary artery pressure
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-glutamineDrug
Oral L-glutamine powder, administered at a dose of 0.1 g/kg/day for 60 days in adult patients with non-transfusion-dependent thalassemia (NTDT). The supplement is given in addition to each participant's standard care regimen (e.g., hydroxyurea or iron chelation therapy, as clinically indicated).
| Study group | Role | What they receive |
|---|---|---|
| L-Glutamine + Standard Care | Experimental | Participants in this arm will receive oral L-glutamine at a dose of 0.1 g/kg/day for 60 days, in addition to their routine standard care for non-transfusion-dependent thalassemia Receives: Drug: L-glutamine |
| Standard Care Alone | No intervention | Standard care may include iron chelation therapy and/or hydroxyurea as prescribed by the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Artery Pressure (PAP)
Pulmonary artery pressure (PAP) will be measured by Doppler echocardiography at baseline and at 60 days. The primary endpoint is the change in PAP (ΔPAP = Follow-up PAP - Baseline PAP) to assess whether L-glutamine reduces pulmonary artery pressure compared with standard care alone.
Measured: Baseline to 60 days
Secondary outcomes (3)
Clinical Response Rate
Proportion of participants achieving either an absolute reduction in PAP ≥10 mmHg or a relative reduction ≥20% from baseline.
Measured: 60 days
Safety and Tolerability of L-Glutamine
Monitoring of adherence, adverse events, and treatment discontinuations related to L-glutamine supplementation.
Measured: Baseline to 60 days
Iron Load
Association between change in pulmonary artery pressure (ΔPAP) and iron overload indices (Cardiac T2*, Liver T2*, and Liver Iron Concentration).
Measured: Baseline to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Aug 2023
- Primary completion22 May 2025
- Study completion27 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery PressureStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rozita Gorzin, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210450
- Sponsor's protocol ID
- IR.MAZUMS.REC.1402.246
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared because of the small sample size, the single-center design, and the need to protect patient privacy. Only aggregated results will be reported in publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glutamine on Reducing Pulmonary Arterial Pressure in Non-transfusion-dependent Thalassemia Patients: a Single Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07210450
- Acronym / sponsor ID
- IR.MAZUMS.REC.1402.246
- Keywords
- L-glutamine, Non-transfusion Dependent Thalassemia, pulmonary artery pressure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 27 Sep 2025 (actual)
- First posted
- 7 Oct 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Glutamine + Standard Care | Experimental | Drug: L-glutamineParticipants in this arm will receive oral L-glutamine at a dose of 0.1 g/kg/day for 60 days, in addition to their routine standard care for non-transfusion-dependent thalassemia |
| Standard Care Alone | No intervention | –Standard care may include iron chelation therapy and/or hydroxyurea as prescribed by the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Age <18 years.
- Refusal or inability to provide informed consent.
- Hepatic dysfunction: ALT >3× upper limit of normal.
- Renal dysfunction: serum creatinine >2× upper limit of normal.
- Known hypersensitivity to L-glutamine.
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 |
|---|---|---|
| L-glutamineOral L-glutamine powder, administered at a dose of 0.1 g/kg/day for 60 days in adult patients with non-transfusion-dependent thalassemia (NTDT). The supplement is given in addition to each participant's standard care regimen (e.g., hydroxyurea or iron chelation therapy, as clinically indicated). | Drug | L-Glutamine + Standard Care |
Primary outcome
Change in Pulmonary Artery Pressure (PAP)
Time frame: Baseline to 60 days
Pulmonary artery pressure (PAP) will be measured by Doppler echocardiography at baseline and at 60 days. The primary endpoint is the change in PAP (ΔPAP = Follow-up PAP - Baseline PAP) to assess whether L-glutamine reduces pulmonary artery pressure compared with standard care alone.
3 secondary outcomes
Clinical Response Rate
Time frame: 60 days
Safety and Tolerability of L-Glutamine
Time frame: Baseline to 60 days
Iron Load
Time frame: Baseline to 60 days
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 7 Oct 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared because of the small sample size, the single-center design, and the need to protect patient privacy. Only aggregated results will be reported in publications or presentations.
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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 2/3 study testing L-glutamine in people with Pulmonary Artery Pressure and Thalassemia, run by Mazandaran University of Medical Sciences at 1 site in Iran.
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 8 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 7 Oct 2025. 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Pulmonary Artery Pressure (PAP) (time frame: Baseline to 60 days). 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 7 Oct 2025.