Clinical trial

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

Name

F.1-1/2015/ERB/SZABMU/747

Description

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.

Trial arms

Trial start

2024-02-01

Estimated PCD

2024-03-15

Trial end

2024-03-15

Status

Not yet recruiting

Phase

Early phase I

Treatment

Ferrous Sulfate Oral Product

ferrous sulphate oral in the form of syrup

Arms:

Daily Group, Twice Weekly Group

Size

160

Primary endpoint

Change in Hemoglobin levels from baseline

4 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'laboratory personnel only will be blind', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

Updated at

2024-01-17

1 organization

1 product

2 indications

Organization

Shaheed Zulfiqar Ali Bhutto Medical University

Product

Ferrous Sulfate

Indication

Cerebral Palsy

Indication

Iron Deficiency Anemia