Iron Deficiency Anemia in Preterm NeaonatesPhase 1NCT07667205
Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates
A Phase 1 study testing Daily oral ferrous ion, Daily oral liposomal iron and Oral liposomal iron every other day in people with Iron Deficiency Anemia in Preterm Neaonates, run by Ain Shams University at 1 site in Egypt.
Trial summary
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily. Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram. Read more about this study
- Who is it for?
- Ages 2 to 3 weeksHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia in Preterm Neaonates
- What is being tested?
- Daily oral ferrous ion, Daily oral liposomal iron and Oral liposomal iron every other day
- 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 siteEgypt
- Study dates
- 25 Jul 2025to 25 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 2 to 3 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm neonates Gestational age ≤ 34 weeks who can tolerate oral feeding.
- Brith weight <2500gm.
Who cannot join
- Major Surgical procedures.
- Major Chromosomal anomaly.
- Inborn error of metabolism.
- GIT anomalies.
- Neonatal sepsis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
Read the detailed description
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
- Administration of the iron thrapy:
- The bottle should be shaken well for at least 30 secend .
- The dose is better to administrated in the morning at least one hour before fed.
4-The bottle should Stored in refrigerator for one month after opening of the bottles.
7.Follow up of the patient:
- Follow up of the patient will be done by phone calls every week .Drug compliance and monitoring of side effect will be recorded.
- All patients Will underwent clinical assessment every 4weeks at the outpatient neonatology clinic for 12 weeks ( total of 3 visits).
At each follow up visit:
Anthropometric measurements: body weight, length and occipito-frontal circumference will be measured and plotted on the Fenton growth chart for preterm neonates.
Compliance to the drug will be assessed and recorded Gastrointestinal side effect (e.g, vomiting, constipation, abdominal distension) will monitored weekly.
Laboratory investigation will be conducted as previously outlined.
- Being tested
- Daily oral ferrous ion, Daily oral liposomal iron, Oral liposomal iron every other day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily oral ferrous ionDrug
Will receive oral ferrous iron
Daily oral liposomal ironDrug
Will receive Daily oral liposomal iron
Oral liposomal iron every other dayDrug
Will receive Oral liposomal iron every other day
| Study group | Role | What they receive |
|---|---|---|
| Standard care group will receive daily oral ferrous iron | Active comparator | will receive daily oral ferrous iron Receives: Drug: Daily oral ferrous ion |
| Daily Liposomal group: will receive daily oral liposomal iron. | Active comparator | will receive daily oral liposomal iron. Receives: Drug: Daily oral liposomal iron |
| -Every other day liposomal group: will receive oral liposomal iron every other day. | Active comparator | will receive oral liposomal iron every other day. Receives: Drug: Oral liposomal iron every other day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration
Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates.
Measured: Baseline before start of oral iron therapy,after that monthly for three months .
Serum ferritin level
Serum ferritin concentration measured in ng/mL to assess iron stores
Measured: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Serum hepcidin level
Serum hepcidin concentration measured in ng/mL.
Measured: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.
Serum iron level
Serum iron concentration measured in µg/dL.
Measured: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Total iron-binding capacity (TIBC)
Total iron-binding capacity measured in µg/dL.
Measured: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Transferrin saturation
Transferrin saturation measured as a percentage (%).
Measured: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start25 Jul 2025
- Primary completion25 Jul 2025
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia in Preterm NeaonatesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667205
- Sponsor's protocol ID
- FMASU MD 144/2025
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07667205
- Acronym / sponsor ID
- FMASU MD 144/2025
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 24 Jun 2026 (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.
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
Detailed description
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.
Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .
- Administration of the iron thrapy:
- The bottle should be shaken well for at least 30 secend .
- The dose is better to administrated in the morning at least one hour before fed.
4-The bottle should Stored in refrigerator for one month after opening of the bottles.
7.Follow up of the patient:
- Follow up of the patient will be done by phone calls every week .Drug compliance and monitoring of side effect will be recorded.
- All patients Will underwent clinical assessment every 4weeks at the outpatient neonatology clinic for 12 weeks ( total of 3 visits).
At each follow up visit:
Anthropometric measurements: body weight, length and occipito-frontal circumference will be measured and plotted on the Fenton growth chart for preterm neonates.
Compliance to the drug will be assessed and recorded Gastrointestinal side effect (e.g, vomiting, constipation, abdominal distension) will monitored weekly.
Laboratory investigation will be conducted as previously outlined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care group will receive daily oral ferrous iron | Active comparator | Drug: Daily oral ferrous ionwill receive daily oral ferrous iron |
| Daily Liposomal group: will receive daily oral liposomal iron. | Active comparator | Drug: Daily oral liposomal ironwill receive daily oral liposomal iron. |
| -Every other day liposomal group: will receive oral liposomal iron every other day. | Active comparator | Drug: Oral liposomal iron every other daywill receive oral liposomal iron every other day. |
Who may qualify
- Ages
- 2 to 3 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm neonates Gestational age ≤ 34 weeks who can tolerate oral feeding.
- Brith weight <2500gm.
Key exclusion criteria (5 listed)
- Major Surgical procedures.
- Major Chromosomal anomaly.
- Inborn error of metabolism.
- GIT anomalies.
- Neonatal sepsis.
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 |
|---|---|---|
| Daily oral ferrous ionWill receive oral ferrous iron | Drug | Standard care group will receive daily oral ferrous iron |
| Daily oral liposomal ironWill receive Daily oral liposomal iron | Drug | Daily Liposomal group: will receive daily oral liposomal iron. |
| Oral liposomal iron every other dayWill receive Oral liposomal iron every other day | Drug | -Every other day liposomal group: will receive oral liposomal iron every other day. |
Primary outcome
Hemoglobin concentration
Time frame: Baseline before start of oral iron therapy,after that monthly for three months .
Hemoglobin level measured in g/dL to assess the effect of daily versus every-other-day liposomal iron supplementation in preterm neonates.
Serum ferritin level
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Serum ferritin concentration measured in ng/mL to assess iron stores
Serum hepcidin level
Time frame: Before start oral iron therapy,after that daily for three days after start of oral iron therapy.
Serum hepcidin concentration measured in ng/mL.
Serum iron level
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Serum iron concentration measured in µg/dL.
Total iron-binding capacity (TIBC)
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Total iron-binding capacity measured in µg/dL.
Transferrin saturation
Time frame: Baseline before starting of oral iron therapy, after that at the end of study after three months.
Transferrin saturation measured as a percentage (%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes
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.
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 1 study testing Daily oral ferrous ion, Daily oral liposomal iron and Oral liposomal iron every other day in people with Iron Deficiency Anemia in Preterm Neaonates, run by Ain Shams University at 1 site in Egypt.
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 2 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: enrolling by invitation, as of the sponsor's last update on 24 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 Egypt. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Hemoglobin concentration (time frame: Baseline before start of oral iron therapy,after that monthly for three months .). The study lists 6 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 24 Jun 2026.