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A clinical trial to compare the effects of iron therapy alone versus combined iron therapy and vitamin D supplementation on cardiovascular functions in children with iron deficiency anemia

Comparison of effect of iron therapy alone versus combined iron therapy and vitamin D supplementation on cardiovascular functions in children with iron deficiency anemia

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004574
Enrollment
30
Registered
2014-04-28
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: null- Iron deficiency anemia

Interventions

Intervention1: sodium feredetate: 4mg/kg daily orally for 8 weeks Control Intervention1: Sodium Feredetate: 4mg/kg daily orally for 8 weeks and Vitamin D (Cholecalciferol) 400 I.U.daily orally for 8

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children between 1-12 years of age with iron deficiency anemia

Exclusion criteria

Exclusion criteria: children with history of fever within last 4 weeks, acute or chronic medical disorders, hemolytic anemia, hemoglobin 6gm%, patients receiving iron/vitamin/mineral supplements(including herbal drugs), blood transfusion within 8 weeks, malignancy,congestive cardiac failure,congenital heart disease/ rheumatic heart disease/ cardiomyopathy, features of rickets

Design outcomes

Primary

MeasureTime frame
changes in heart rate, ,cardiac output,left ventricular early diastolic filling, left ventricular preload and afterload,cardiac index LV fractional shortening/ LV ejection fraction,LV end-diastolic and end-systolic dimensions and wall thickness Ratio of end-systolic wall stress to end-systolic volume index (ESS/ESVI),cardiac pressures Timepoint: 8 weeks

Secondary

MeasureTime frame
changes in haemoglobin, MCV, MCH, MCHC, RDW Timepoint: 4 and 8 weeks

Countries

India

Contacts

Public ContactDr Zeeba ZakaurRab

Deptt. of Pediatrics, J.N. Med. College, A.M.U.

zzrab@yahoo.co.in0571-2402928

Outcome results

None listed

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