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

NCT ID: NCT07210450

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2025-09-27

Brief 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 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.

Conditions

Pulmonary Artery Pressure; Thalassemia; Non-transfusion Dependent Thalassemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

L-Glutamine + Standard Care

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

Group Type: EXPERIMENTAL

L-glutamine

Intervention Type: 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).

Standard Care Alone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

L-glutamine

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).

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mazandaran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Rozita Gorzin

Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bu'Ali Sina Hospital

Sari, Mazandaran, Iran

Countries

Iran

Other Identifiers

IR.MAZUMS.REC.1402.246

Identifier Type: -

Identifier Source: org_study_id