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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy, Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Ferrous Sulfate Oral Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia Age 06 months to 5 years Both genders Exclusion Criteria: >5 years of age Children with severe anaemia requiring transfusion (Hb<5 g/L) Children with history of taking oral/IV iron supplements or repeated blood transfusions during last one month Children with concomitant diarrheal disease Where parents are not willing to participate in the study

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daily Group<br>one group will receive ferrous sulphate 3mg/kg in the form of syrup daily | Drug: Ferrous Sulfate Oral Product<br>* ferrous sulphate oral in the form of syrup<br>|
| Sham Comparator: Twice Weekly Group<br>other group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly. | Drug: Ferrous Sulfate Oral Product<br>* ferrous sulphate oral in the form of syrup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin levels from baseline | rise in Hb at the end of 4 weeks as more than equal to 1g/dl | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in MCV (Mean Corpuscular Volume) | mean change from baseline at the end of 4 weeks | 4 weeks | 
| Mean change in mean corpuscular hemoglobin concentration (MCHC) | mean change from baseline at the end of 4 weeks | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, anemia