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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06176430
• Other study ID #: F.1-1/2015/ERB/SZABMU/747
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cerebral Palsy
• Iron Deficiency Anemia
• Paralysis

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