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

NCT07210450 | Completed Phase 2

• 1 other identifier: IR.MAZUMS.REC.1402.246
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

L-glutamine; Non-transfusion Dependent Thalassemia; pulmonary artery pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 60 days

Secondary Outcomes (3)

• Clinical Response Rate

  60 days

• Safety and Tolerability of L-Glutamine

  Baseline to 60 days

• Iron Load

  Baseline to 60 days

Study Arms (2)

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

Drug: L-glutamine

Standard Care Alone

NO INTERVENTION

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

Interventions

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).

L-Glutamine + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Bu'Ali Sina Hospital

Sari, Mazandaran, 4815738477, Iran

Location

MeSH Terms

Conditions

Thalassemia

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: August 15, 2023
• Primary Completion: May 22, 2025
• Study Completion: September 27, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

IR (1)