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

January 16, 2024 updated by: Dr Yusra Kafait, Shaheed Zulfiqar Ali Bhutto Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Daily Group
one group will receive ferrous sulphate 3mg/kg in the form of syrup daily
Drug: Ferrous Sulfate Oral Product
ferrous sulphate oral in the form of syrup
Sham Comparator: Twice Weekly Group
other group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly.
Drug: Ferrous Sulfate Oral Product
ferrous sulphate oral in the form of syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin levels from baseline
Time Frame: 4 weeks
rise in Hb at the end of 4 weeks as more than equal to 1g/dl
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in MCV (Mean Corpuscular Volume)
Time Frame: 4 weeks
mean change from baseline at the end of 4 weeks
4 weeks
Mean change in mean corpuscular hemoglobin concentration (MCHC)
Time Frame: 4 weeks
mean change from baseline at the end of 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Investigators

  • Principal Investigator: Yusra Kafait, MBBS, Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.1-1/2015/ERB/SZABMU/747

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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