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

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• Thalassemia 416

Keywords

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

Thalassemia

416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.

This study's enrollment of 8 is below the median of 37 across 277 interventional studies indexed under Thalassemia.

Lead sponsor

Mazandaran University of Medical Sciences is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  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

  Drug: L-glutamine

• No intervention
  Standard Care Alone

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

Interventions

• DrugL-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).

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.

   Time frame: Baseline to 60 days

Secondary outcomes

1. Clinical Response Rate

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

   Time frame: 60 days

2. Safety and Tolerability of L-Glutamine

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

   Time frame: Baseline to 60 days

3. Iron Load

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

   Time frame: Baseline to 60 days

Individual participant data

Plan to share: 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.