To study the effect of an oral drug, N-Acetylcysteine on reducing the quantity of blood transfusion requirement in children with Beta thalassemia who are alreaady receiving regular blood transfusion

The effect of N-Acetylcysteine on red blood cell transfusion burden in transfusion dependent Beta thalassemia children A open labelled experimental study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077412

Enrollment

Registered

2024-11-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

Intervention1: Use of N-Acetylcysteine: Use of N-Acetylcysteine - 10 mg/kg/day administered orally for a period of 3 months Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: All transfusion dependent Beta thalassemia children on regular blood transfusion and iron chelation therapy Serum ferritin 2500-3000ng/ml

Exclusion criteria

Exclusion criteria: Renal/hepatic impairment Change in dose of iron chelater within three months before enrolment Alloimmunisation

Design outcomes

Primary

Measure	Time frame
Reduction in burden of RBC transfusion Increase in hemoglobin levelsTimepoint: 1. Total volume of blood transfused over the last three months will be assessed at baseline prior to starting N-Acetylcisteine. At the end of study period, the volume of blood transfused over the last 3 months will be assessed 2. Pre-transfusion Hb will be checked at baseline, every 3 weeks and at the end of study period.	—

Measure

Time frame

Reduction in burden of RBC transfusion Increase in hemoglobin levelsTimepoint: 1. Total volume of blood transfused over the last three months will be assessed at baseline prior to starting N-Acetylcisteine. At the end of study period, the volume of blood transfused over the last 3 months will be assessed 2. Pre-transfusion Hb will be checked at baseline, every 3 weeks and at the end of study period.

—

Secondary

Measure	Time frame
Decrease in Serum ferritinTimepoint: Serum ferritin will be checked at baseline, at the end of 3 months	—

Countries

India

Contacts

Public ContactDr Shajathi Begum N

Institute of child health,Egmore,Chennai

shaju9875@gmail.com9524543046

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026