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Folic acid supplementation in thalassemia patients receiving regular blood transfusions

Optimum dose of oral folic acid supplementation in transfusion-dependent thalassemia major

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023895
Enrollment
100
Registered
2020-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Administration of folic acid in different doses: Folic acid will be administered as - 5mg in Group 1, 2.5mg in Group 2 and 5mg per week in Group 3 Control Intervention1: Folic acid in d

Sponsors

University college of Medical Sciences and Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Transfusion dependent thalassemia major patients aged 5 to 18 years will be included

Exclusion criteria

Exclusion criteria: Patients deficient in folate and Vit. B12, splenectomized patients, patients with chronic liver disease, Hepatitis B or C infection, patients taking medicines affecting folate metabolism (cotrimoxazole or methotrexate) will be excluded

Design outcomes

Primary

MeasureTime frame
Proportion of children with folate excess( serum folate more than or equal to 20ng/ml) after 6 months of therapyTimepoint: 6 months

Secondary

MeasureTime frame
Blood transfusion requirement over 6 monthsTimepoint: 6 months;Mean corpuscular volume , Reticulocyte count after 6 months of therapyTimepoint: 6 months of therapy;Proportion of children with folate deficiency (less than 2 ng/ml)Timepoint: 6 months;RBC and serum folate levels and homocysteine levels after 6 months of therapyTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Titiksha Agrawal

Guru Teg Bahadur Hospital

ttksha.agrwl34@gmail.com7727834303

Outcome results

None listed

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