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

Shaheed Zulfiqar Ali Bhutto Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Iron Deficiency Anemia; Cerebral Palsy

Treatments: Drug: Ferrous Sulfate Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06176430

F.1-1/2015/ERB/SZABMU/747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6 to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Daily Group

Active Comparator group

Description:

one group will receive ferrous sulphate 3mg/kg in the form of syrup daily

Treatment:

Drug: Ferrous Sulfate Oral Product

Twice Weekly Group

Sham Comparator group

Description:

other group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly.

Treatment:

Drug: Ferrous Sulfate Oral Product