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Role of N-acetylcysteine in reducing cardiac iron overload in children with transfusion-dependent thalassemia.

Effect of N-acetylcysteine on cardiac iron status in transfusion dependent thalassemia children - A Randomized control trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098993
Enrollment
60
Registered
2025-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: N -acetylcysteine: Intervention group will receive oral N-acetylcysteine 10 mg/kg once daily for 6 months, administered with food along with standard iron chelation therapy. Control I

Sponsors

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 10 to 18 years diagnosed with beta thalassemia( on regular transfusion for 1 year)

Exclusion criteria

Exclusion criteria: Children with either of the following conditions will be excluded: 1.Children with documented renal and liver dysfunction/endocrine/ cardiac dysfunction 2.Receiving any supplementation (other than folic acid) within the past one month 3.Child on any cardioprotective drugs 4.Known hypersensitivity to N-acetylcysteine 5.Refusal of consent by parent/guardian

Design outcomes

Primary

MeasureTime frame
Change in cardiac iron statusTimepoint: At enrollment and after 6 months

Secondary

MeasureTime frame
Changes in MIC and echo findings in relation to serum ferritin levels after 6 months of NAC supplementation. Frequency of transfusions requirements (e.g. Average pre-transfusion haemoglobin, average transfusion interval, average transfusion volume) during study period. Any adverse effects related to NAC (infections, hospitalization, worsening anaemia). Timepoint: at 0, 3 , 6 months

Countries

India

Contacts

Public ContactDr Keshika

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYANA

bansalkeshika389@gmail.com8168328951

Outcome results

None listed

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