Ferrous Ascorbate in the treatment of IDA

Phase 4

Completed

• Conditions: Iron deficiency,

• Registration Number: CTRI/2010/091/002994
• Lead Sponsor: Zuventus Healthcare Ltd

Brief Summary

the present study compares the efficacy of ferrous ascorbate and colloidal iron in the treatment of Iron deficiency anemia in children. Children eligible for inclusion will be randomized to receive either Feronia-XT or Tonoferon for a period of 3 months. the dosage of the iron supplementation will be calculated such that each child receives 3 mg/kg elemental iron for 12 weeks. Assessment for the change in iron indices will be performed at the baseline (Day 0), Week 4, Week 8 and Week 12.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Study Completion: 2009-11-30
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

?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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in hemoglobin level	End of week 4, Week 8, week 12

Secondary Outcome Measures

Name	Time	Method
1. Change in hemoglobin levels based on the severity of anemia at baseline (moderate anemia corresponds to a level of 7.0-9.9 gm%	while severe anemia corresponds to a level less than 7.0 gm%),

Trial Locations

Locations (1)

NRS Medical College and Hospital.; 🇮🇳 Kolkata, WEST BENGAL, India

NRS Medical College and Hospital.

🇮🇳Kolkata, WEST BENGAL, India

Dr. Sutapa Ganguly

Principal investigator

9831369441

sutapaganguly@hotmail.com