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NCT Number: NCT07210450

Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia

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.

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Key information

Conditions

Pulmonary Artery Pressure Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Non-transfusion Dependent Thalassemia Thalassemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bu'Ali Sina Hospital

Sari, Mazandaran, 4815738477, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

L-glutamine

Drug

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical Response Rate

    Time frame: 60 days

    Proportion of participants achieving either an absolute reduction in PAP ≥10 mmHg or a relative reduction ≥20% from baseline.

  2. Safety and Tolerability of L-Glutamine

    Time frame: Baseline to 60 days

    Monitoring of adherence, adverse events, and treatment discontinuations related to L-glutamine supplementation.

  3. Iron Load

    Time frame: Baseline to 60 days

    Association between change in pulmonary artery pressure (ΔPAP) and iron overload indices (Cardiac T2*, Liver T2*, and Liver Iron Concentration).

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

The Effect of Glutamine on Reducing Pulmonary Arterial Pressure in Non-transfusion-dependent Thalassemia Patients: a Single Blind Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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