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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Group | Active Comparator | one group will receive ferrous sulphate 3mg/kg in the form of syrup daily |
|
| Twice Weekly Group | Sham Comparator | other group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate Oral Product | Drug | ferrous sulphate oral in the form of syrup |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusra Kafait, MBBS | Contact | 03075853560 | yusratooba@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yusra Kafait, MBBS | Shaheed Zulfiqar Ali Bhutto Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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laboratory personnel only will be blind
| 4 weeks |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |