Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy

Phase 4

Not yet recruiting

• Conditions: Cerebral Palsy; Iron Deficiency Anemia
• Interventions: Drug: Ferrous Sulfate Oral Product

• Registration Number: NCT06176430
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Brief Summary

a randomized clinical trial to compare the effect of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy, to be conducted at Department of pediatric medicine children's hospital PIMS islamabad.

Detailed Description

a total of 160 children of either gender with age between 6 and 60 months diagnosed with cerebral palsy and concomitant iron deficiency anemia will be enrolled, they will be allocated two groups by lottery method. one group will be given ferrous sulphate 3mg/kg daily in the form of syrup and other group will be given ferrous sulphate 3mg/kg twice weekly in the form of syrup for a period of 4 weeks. the primary outcome will be measured as rise in hemoglobin levels more than or equal to 1g/dl at 4 weeks.

Study Timeline

• Study First Submitted: 2023-12-09
• Study First Submitted QC: 2023-12-09
• Study First Posted: 2023-12-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Study Start: 2024-02-01
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia
2. Age 06 months to 5 years
3. Both genders

Exclusion Criteria

1. >5 years of age
2. Children with severe anaemia requiring transfusion (Hb<5 g/L)
3. Children with history of taking oral/IV iron supplements or repeated blood transfusions during last one month
4. Children with concomitant diarrheal disease
5. Where parents are not willing to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Group	Ferrous Sulfate Oral Product	one group will receive ferrous sulphate 3mg/kg in the form of syrup daily
Twice Weekly Group	Ferrous Sulfate Oral Product	other group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin levels from baseline	4 weeks	rise in Hb at the end of 4 weeks as more than equal to 1g/dl

Secondary Outcome Measures

Name	Time	Method
Mean change in MCV (Mean Corpuscular Volume)	4 weeks	mean change from baseline at the end of 4 weeks
Mean change in mean corpuscular hemoglobin concentration (MCHC)	4 weeks	mean change from baseline at the end of 4 weeks