Iron Deficiency Anemia TreatmentPhase 4NCT04267653
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
A Phase 4 study testing Lactoferrin Bovine and Ferrous Sulfate in people with Iron Deficiency Anemia Treatment, run by Assiut University at 1 site in Egypt.
Trial summary
Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Iron Deficiency Anemia Treatment
- What is being tested?
- Lactoferrin Bovine and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Oct 2018
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Anemia rather than iron deficiency anemia.
- Family history of blood disease.
- Patients with thalassemia trait.
- Patients with chronic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens
- Conditions
- Iron Deficiency Anemia Treatment
- Being tested
- Lactoferrin Bovine, Ferrous Sulfate
- Keywords
- Iron deficiency anemia, Lactoferrin, Ferrous 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.
Lactoferrin BovineDrug
Also called Pravotin sachet
treatment for 30 days
Ferrous SulfateDrug
Also called ferrovit syrup
treatment for 30 days
| Study group | Role | What they receive |
|---|---|---|
| lactoferrin | Active comparator | Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach Receives: Drug: Lactoferrin Bovine |
| ferrous sulfate | Active comparator | Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses Receives: Drug: Ferrous Sulfate |
| combined | Active comparator | combined therapy (both lactoferrin and ferrous sulfate) Receives: Drug: Lactoferrin Bovine; Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)
Measured: 30 days
Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Total serum iron(ug/d) will be done before and after therapy to detect effect of the therapy on total serum iron level (ug/d)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gaber Ahmed, Assiut University
- Investigators
- Ahmed Gaber Ahmed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267653
- Sponsor's protocol ID
- 17100915
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT04267653
- Acronym / sponsor ID
- 17100915
- Conditions
- Iron Deficiency Anemia Treatment
- Keywords
- Iron deficiency anemia, Lactoferrin, Ferrous sulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 13 Feb 2020 (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.
Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lactoferrin | Active comparator | Drug: Lactoferrin BovineOral bovine lactoferrin (bfl) 100 mg once daily on empty stomach |
| ferrous sulfate | Active comparator | Drug: Ferrous SulfateOral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses |
| combined | Active comparator | Drug: Lactoferrin Bovine, Drug: Ferrous Sulfatecombined therapy (both lactoferrin and ferrous sulfate) |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Anemia rather than iron deficiency anemia.
- Family history of blood disease.
- Patients with thalassemia trait.
- Patients with chronic illness.
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 |
|---|---|---|
| Lactoferrin BovineAlso: Pravotin sachettreatment for 30 days | Drug | combined, lactoferrin |
| Ferrous SulfateAlso: ferrovit syruptreatment for 30 days | Drug | combined, ferrous sulfate |
Primary outcome
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Time frame: 30 days
Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)
Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
Time frame: 30 days
Total serum iron(ug/d) will be done before and after therapy to detect effect of the therapy on total serum iron level (ug/d)
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 13 Feb 2020.
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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.
Ahmed Gaber Ahmed principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactoferrin Bovine and Ferrous Sulfate in people with Iron Deficiency Anemia Treatment, run by Assiut 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 0 inclusion and 4 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 13 Feb 2020. 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 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?
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?
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia. (time frame: 30 days). 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 13 Feb 2020.