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A study of two marketed formulations containing iron in anemic children.

Efficacy and safety of Ferrous Ascorbate and Colloidal Iron in pediatric patients with iron deficiency anemia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2009/091/000994
Enrollment
120
Registered
2010-04-19
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: E611- Iron deficiency

Interventions

Intervention1: Feronia- XT Suspension: Elemental Iron 3 Mg/ Kg Body Weight Will Be Given In Two Divided Doses For A Period Of 12 Weeks. Control Intervention1: Tonoferon Syrup: Elemental Iron 3 Mg/ Kg

Sponsors

Zuventus Healthcare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Children between the age group of 6 months to 12 years. - Children having iron deficiency anemia with hemoglobin less than 10 gm%. - Patients who would be coming for follow up after every 4 weeks for the complete study period of 12 weeks. - Informed written consent given by parents/guardians of the patients.

Exclusion criteria

Exclusion criteria: - Anemia due to other causes than iron deficiency anemia - Severe concurrent illness (cardiovascular, renal, hepatic). - Known hypersensitivity to Ferrous ascorbate or any other iron preparations - Malignancy of any type. ? Children with thalassemia major / aplastic or hypoplastic anaemia, sickle cell anaemia, any other abnormal haemoglobinopathy or any other haemolytic anaemia. - Any other condition that in the opinion of the investigator does not justify the patient's inclusion.

Design outcomes

Primary

MeasureTime frame
effect on iron indicesTimepoint: day 0 and week 12;effect on iron indicesTimepoint: day 0 and week 12

Secondary

MeasureTime frame
adverse events reportedTimepoint: at the end of week 4, week 8 and week 12

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Ltd.

medico@zuventus.com022-30610000

Outcome results

None listed

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