Cerebral PalsyPhase 4NCT06176430
Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy
A Phase 4 study testing Ferrous Sulfate Oral Product in people with Cerebral Palsy and Iron Deficiency Anemia, run by Shaheed Zulfiqar Ali Bhutto Medical University.
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. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Cerebral Palsy, Iron Deficiency Anemia
- What is being tested?
- Ferrous Sulfate Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 15 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia
- Age 06 months to 5 years
- Both genders
Who cannot join
- >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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Cerebral Palsy, Iron Deficiency Anemia
- Being tested
- Ferrous Sulfate Oral Product
- Keywords
- cerebral palsy, anemia
- Medical subject headings
- Cerebral Palsy, Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Sulfate Oral ProductDrug
ferrous sulphate oral in the form of syrup
| Study group | Role | What they receive |
|---|---|---|
| Daily Group | Active comparator | one group will receive ferrous sulphate 3mg/kg in the form of syrup daily Receives: 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. Receives: Drug: Ferrous Sulfate Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin levels from baseline
rise in Hb at the end of 4 weeks as more than equal to 1g/dl
Measured: 4 weeks
Secondary outcomes (2)
Mean change in MCV (Mean Corpuscular Volume)
mean change from baseline at the end of 4 weeks
Measured: 4 weeks
Mean change in mean corpuscular hemoglobin concentration (MCHC)
mean change from baseline at the end of 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yusra Kafait, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Yusra Kafait, MBBS, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176430
- Sponsor's protocol ID
- F.1-1/2015/ERB/SZABMU/747
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06176430
- Acronym / sponsor ID
- F.1-1/2015/ERB/SZABMU/747
- Conditions
- Cerebral Palsy, Iron Deficiency Anemia
- Keywords
- cerebral palsy, anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Group | Active comparator | Drug: Ferrous Sulfate Oral Productone group will receive ferrous sulphate 3mg/kg in the form of syrup daily |
| Twice Weekly Group | Sham comparator | Drug: Ferrous Sulfate Oral Productother group will receive ferrous sulphate 3mg/kg in the form of syrup twice weekly. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia
- Age 06 months to 5 years
- Both genders
Key exclusion criteria (5 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous Sulfate Oral Productferrous sulphate oral in the form of syrup | Drug | Daily Group, Twice Weekly Group |
Primary outcome
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
2 secondary outcomes
Mean change in MCV (Mean Corpuscular Volume)
Time frame: 4 weeks
Mean change in mean corpuscular hemoglobin concentration (MCHC)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusra Kafait, MBBS principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous Sulfate Oral Product in people with Cerebral Palsy and Iron Deficiency Anemia, run by Shaheed Zulfiqar Ali Bhutto Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yusra Kafait, MBBS (03075853560, yusratooba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin levels from baseline (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.