Iron Deficiency AnemiaPhase 4NCT06550362
Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA
A Phase 4 study testing iron sulfate in people with Iron Deficiency Anemia, run by Loma Linda University.
Trial summary
Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- iron sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to May 2027
- Phase
- Phase 4
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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed Iron Deficiency Anemia
- Pediatric patients (1-18 years of age) without regard of gender, race, ethnicity nor language.
- Able and willing to take oral iron (tablet or liquid).
Who cannot join
- Pregnant or lactating patients
- Known allergies or intolerance to oral iron formulations
- Concomitant chronic medical conditions affecting iron metabolism
- Short gut syndrome
- Celiac disease
- Inflammatory bowel disease
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- Cancer
- Chronic kidney disease
- Blood transfusions in the past 3 months
- IV iron administration in the past 3 months
- Oral iron supplementation in the past 2 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Noela Ndrekaj, PharmD contact
About this study
Official title: A Randomized Controlled Trial Comparing Daily Oral Iron Administration to Every Alternate Day Iron Administration in the Treatment of Iron Deficiency Anemia in Pediatric Patients.
Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. This study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of IDA in pediatric patients.
Read the detailed description
This is a prospective open-label randomized controlled study. Patients will be randomized into two groups, one group (investigational) will receive oral iron every other day (every 48 hours) and the control group will be prescribed daily oral iron. Data will be collected prospectively including compliance assessment, side effect profile, hemoglobin (CBC), iron stores, hepcidin levels and other monitoring as relevant for best patient care.
At the time of enrollment and following randomization patients will commence treatment with oral iron. Duration of treatment will be 3 months. Laboratory monitoring will also commence at the time of enrollment along with ongoing evaluation of signs and symptoms of anemia, side effects of oral iron therapy, compliance with oral iron therapy. Duration of monitoring will be 6 months.
A medication diary will be provided to all subjects of each group to track their intake of their oral iron supplementation.
- Conditions
- Iron Deficiency Anemia
- Being tested
- iron sulfate
- 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.
iron sulfateDrug
Oral iron administration
| Study group | Role | What they receive |
|---|---|---|
| Iron every other day | Experimental | Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day. Receives: Drug: iron sulfate |
| Iron every day | Active comparator | Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day. Receives: Drug: iron sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin stabilization
Hemoglobin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if hemoglobin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe.
Measured: Change between baseline and 3 months post-enrollment
Serum Ferritin stabilization
Serum Ferritin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if Serum Ferritin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe.
Measured: Change between baseline and 3 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Kheradpour, MD, Principal investigator, Loma Linda Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550362
- Sponsor's protocol ID
- 5240248
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD with other researchers. Only study results will be shared.