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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06176430
Other study ID # F.1-1/2015/ERB/SZABMU/747
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2024
Est. completion date March 15, 2024

Study information

Verified date January 2024
Source Shaheed Zulfiqar Ali Bhutto Medical University
Contact Yusra Kafait, MBBS
Phone 03075853560
Email yusratooba@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date March 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 60 Months
Eligibility 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


Intervention

Drug:
Ferrous Sulfate Oral Product
ferrous sulphate oral in the form of syrup

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean change in MCV (Mean Corpuscular Volume) mean change from baseline at the end of 4 weeks 4 weeks
Secondary Mean change in mean corpuscular hemoglobin concentration (MCHC) mean change from baseline at the end of 4 weeks 4 weeks
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