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

Mazandaran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-transfusion Dependent Thalassemia; Pulmonary Artery Pressure; Thalassemia

Treatments: Drug: L-glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07210450

IR.MAZUMS.REC.1402.246

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

L-Glutamine + Standard Care

Experimental group

Description:

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

Treatment:

Drug: L-glutamine

Standard Care Alone

No Intervention group

Description:

Standard care may include iron chelation therapy and/or hydroxyurea as prescribed by the treating physician.