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

NCT06176430 | Unknown Phase 4

• 1 other identifier: F.1-1/2015/ERB/SZABMU/747
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy; Iron Deficiency Anemia

Keywords

cerebral palsy, anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean change in MCV (Mean Corpuscular Volume)

  4 weeks

• Mean change in mean corpuscular hemoglobin concentration (MCHC)

  4 weeks

Study Arms (2)

Daily Group

ACTIVE COMPARATOR

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

Drug: Ferrous Sulfate Oral Product

Twice Weekly Group

SHAM COMPARATOR

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

Drug: Ferrous Sulfate Oral Product

Interventions

Ferrous Sulfate Oral Product DRUG

ferrous sulphate oral in the form of syrup

Daily Group; Twice Weekly Group

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia
• Age 06 months to 5 years
• Both genders

You may not qualify if:

• \>5 years of age
• Children with severe anaemia requiring transfusion (Hb\<5 g/L)
• Children with history of taking oral/IV iron supplements or repeated blood transfusions during last one month
• Children with concomitant diarrheal disease
• Where parents are not willing to participate in the study

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

MeSH Terms

Conditions

Cerebral Palsy; Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yusra Kafait, MBBS

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yusra Kafait, MBBS

CONTACT

03075853560; yusratooba@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: laboratory personnel only will be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrics Resident

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: December 19, 2023
• Study Start: February 1, 2024
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01