Iron Deficiency AnemiaPhase 3NCT07267975
Effectiveness of Oral Iron Therapy in Iron Deficiency Anemia With Daily vs Alternate Day Dosing
A Phase 3 study testing Ferrous sulphate in people with Iron Deficiency Anemia and Iron Deficiency Anemia Treatment, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial summary
Treating iron deficiency anemia in children with daily and alternate day oral iron therapy Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
- What is being tested?
- Ferrous sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Jan 2025to 7 May 2025
- Phase
- Phase 3
- 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 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both genders with ages in the range of 0 -60 months suffering from IDA as per operational definition.
Who cannot join
- Who have already taken treatment for IDA during last 2-months as per history/clinical record.
- Who have undergone recent blood transfusion during last 12-weeks as per history/clinical record.
- Children with chronic kidney disease, chronic liver disease, cardiac failure or concomitant malignancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of child health science and the children hospital lahore
Lahore, Punjab Province, 54000
About this study
Official title: Effectiveness of Intermittent Oral Iron Therapy vs Continuous Oral Iron Therapy in Treating Iron Deficiency Anemia Patients UpTo 5 Year of Age; a Randomized Control Trial
Treating iron deficiency anemia in children with daily and alternate day oral iron therapy
Read the detailed description
Comparison of effectiveness of oral iron in daily and alternate group in children
- Being tested
- Ferrous sulphate
- Keywords
- Oral iron, Children, IDA
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulphateDrug
Also called Daily dosing
Continuous vs intermittent oral iron therapy to see the difference of Hemoglobin rose in both group
Ferrous sulphateDrug
Also called Intermittent, alternate day dosing
Pattern of Rise in hemoglobin in alternate day doaung
| Study group | Role | What they receive |
|---|---|---|
| Continuous oral iron therapy | Active comparator | Oral iron daily dosing 6mg/kg/day Receives: Drug: Ferrous sulphate |
| Intermittent oral iron | Experimental | Oral iron therapy on alternate day with dose of 6mg /kg/day for 3 mons Receives: Drug: Ferrous sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rise in hemoglobin level after oral iron
Hemoglobin level change in g/dl
Measured: 3 months
Change in Hemoglobin level
Hb rise in g/dl
Measured: 3month
Secondary outcomes (1)
Rise in ferritin level
Ferritin level change in ng/ml
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start7 Jan 2025
- Primary completion7 Mar 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marryam Kaleem, University of Child Health Sciences and Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267975
- Sponsor's protocol ID
- No/1032/CH-UCHS
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intermittent Oral Iron Therapy vs Continuous Oral Iron Therapy in Treating Iron Deficiency Anemia Patients UpTo 5 Year of Age; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07267975
- Acronym / sponsor ID
- No/1032/CH-UCHS
- Keywords
- Oral iron, Children, IDA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 5 Dec 2025 (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.
Treating iron deficiency anemia in children with daily and alternate day oral iron therapy
Detailed description
Comparison of effectiveness of oral iron in daily and alternate group in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous oral iron therapy | Active comparator | Drug: Ferrous sulphateOral iron daily dosing 6mg/kg/day |
| Intermittent oral iron | Experimental | Drug: Ferrous sulphateOral iron therapy on alternate day with dose of 6mg /kg/day for 3 mons |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients of both genders with ages in the range of 0 -60 months suffering from IDA as per operational definition.
Key exclusion criteria (3 listed)
- Who have already taken treatment for IDA during last 2-months as per history/clinical record.
- Who have undergone recent blood transfusion during last 12-weeks as per history/clinical record.
- Children with chronic kidney disease, chronic liver disease, cardiac failure or concomitant malignancy
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 sulphateAlso: Daily dosingContinuous vs intermittent oral iron therapy to see the difference of Hemoglobin rose in both group | Drug | Continuous oral iron therapy |
| Ferrous sulphateAlso: Intermittent, alternate day dosingPattern of Rise in hemoglobin in alternate day doaung | Drug | Intermittent oral iron |
Primary outcome
Rise in hemoglobin level after oral iron
Time frame: 3 months
Hemoglobin level change in g/dl
Change in Hemoglobin level
Time frame: 3month
Hb rise in g/dl
1 secondary outcome
Rise in ferritin level
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Confidentiality
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous sulphate in people with Iron Deficiency Anemia and Iron Deficiency Anemia Treatment, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rise in hemoglobin level after oral iron (time frame: 3 months). The study lists 2 primary outcomes in all. 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 16 Jun 2026.