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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06176430

Enrollment

160

Registered

2023-12-19

Start date

2024-02-01

Completion date

2024-03-15

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Iron Deficiency Anemia

Keywords

cerebral palsy, anemia

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.

Interventions

DRUGFerrous Sulfate Oral Product

ferrous sulphate oral in the form of syrup

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

laboratory personnel only will be blind

Eligibility

Sex/Gender

ALL

Age

6 Months to 60 Months

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactYusra Kafait, MBBS

yusratooba@gmail.com03075853560

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026