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Not yet recruitingNCT06176430Updated Jan 17, 2024

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

A Phase 4 interventional study of Ferrous Sulfate Oral Product in Cerebral Palsy and Iron Deficiency Anemia, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Not yet recruiting. Open to participants aged 6 Months to 60 Months. Per ClinicalTrials.gov, last updated 2024-01-17.

Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
6 Months to 60 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Iron Deficiency Anemia

Keywords

  • cerebral palsy, anemia
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 160 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 37 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. >5 years of age
  2. Children with severe anaemia requiring transfusion (\<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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Daily Group

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

    Drug: Ferrous Sulfate Oral Product

  • 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

Interventions

06

What researchers measure

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

    Time frame: 4 weeks

Secondary outcomes

  1. Mean change in MCV (Mean Corpuscular Volume)

    mean change from baseline at the end of 4 weeks

    Time frame: 4 weeks

  2. Mean change in mean corpuscular hemoglobin concentration (MCHC)

    mean change from baseline at the end of 4 weeks

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06176430
Lead sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Responsible party
Dr Yusra Kafait (Pediatrics Resident, Shaheed Zulfiqar Ali Bhutto Medical University) — Principal investigator
First posted
Dec 19, 2023
Start date
Feb 1, 2024 (estimated)
Primary completion
Mar 15, 2024 (estimated)
Completion
Mar 15, 2024 (estimated)
Last update
Jan 17, 2024

Study contacts

Yusra Kafait, MBBS
Contact
yusratooba@gmail.com
03075853560
Yusra Kafait, MBBS
principal investigator · Shaheed Zulfiqar Ali Bhutto Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ferrous sulfate

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