Iron Deficiency AnemiaPhase 4NCT05921968
Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia
A Phase 4 study testing Intravenous iron sucrose and Lactoferrin in people with Iron Deficiency Anemia, run by Ain Shams University.
Trial summary
Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Intravenous iron sucrose and Lactoferrin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 1 Apr 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with iron deficiency anemia.
- Microcytic hypochromic anemia, moderate anemia (Hb 8 to 9.9 g/dl) and S. Ferritin levels <12 ng/dl as per WHO guidelines
- Gestational age: - 13-26 weeks.
- Singleton viable pregnancy
- Lastly, agreement to participate and sign the informed consent was a basic prerequisite
Who cannot join
- Women with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemia trait).
- Severe anemia <7 g/dl requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities.
- History of peptic ulcer.
- Hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry.
- Suspected acute infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy
Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy.
Read the detailed description
Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy.
The study will include 100 pregnant women with moderate iron deficiency anemia. They will assigned randomly in to 2 groups. Each group will contain 50 patients.
The first group will receive intravenous iron sucrose (sacrofer 100mg/5ml)as 200 mg elemental iron in 100 ml 0.9 NaCl over 20-30 minutes up to the total dose -Total dose will be calculated from this equation=weight(kg)x(target Hb in g/dl-actual Hb in g/dl)x2.4+500 rounded up to the nearest multiple of 100 mg The second group will receive lactoferrin 100 mg twice daily orally before breakfast and before dinner (pravotin 100 mg sachets will be dissolved in ¼ glass of water). Patients will be advised to avoid coffee, milk products and antacid before and after the dose of lactoferrin.
- Baseline assessment:
All women in the study will be submitted to:
- Complete History Taking Including:
- Personal history: This included name, age, duration of marriage, last menstrual period, parity, occupation and special habits.
- 1st day of last menstrual period.
- Estimated gestational age
- Contraceptive history
- Obstetric history Including:
- Full details of previous pregnancies (Date, outcome, onset and mode of delivery, gestational age at delivery and any associated complication or history of similar disorder, spacing between each pregnancy.
- General Examination Included: Weight, height, body Mass Index (BMI), temperature, pulse, blood pressure, chest and cardiac examination, signs of anemia
- Abdominal Examination
- Fetal monitoring: To confirm fetal maturity and fetal wellbeing by non-stress test and biophysical profile.
- U/S investigation: To confirm gestational age and exclude associated congenital anomalies.
Investigations:
- Complete blood sample (CBC), total iron binding capacity and Transferrin saturation will be done in Ain Shams Maternity Hospital Labs.
- Serum ferritin will be sent to any private lab.
- Kidney function tests and liver function tests. 2. Follow up assessment:
- Anemic pregnant women will be followed up every 4 weeks until delivery.
- In between visits, patients will be contacted via phone for monitoring of any side effects.
- End of study assessment:
- the same laboratory tests will be done with monitoring of any signs or symptoms of anemia until Hb level > 11 g/dl
- Conditions
- Iron Deficiency Anemia
- Being tested
- Intravenous iron sucrose, Lactoferrin
- Keywords
- Anemia in pregnancy, Lactoferrin, Iron Sucrose
- 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.
Intravenous iron sucroseDrug
Also called Intravenous iron sucrose(Sacrofer 100mg/5ml) was manufactured by Amoun company for pharmaceutical and chemical industry ,Egypt.
200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose)
- The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg
LactoferrinDrug
Also called lactoferrin 100 mg (Pravotin100 mg sachet)was manufactured by Hygint company for pharmaceutical and chemical industry,Egypt. Egypt) twice daily orally .
100 mg twice daily orally before breakfast and dinner
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Iron Sucrose group | Active comparator | 50 pregnant women will receive 200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose
-The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg Receives: Drug: Intravenous iron sucrose |
| Lactoferrin group | Active comparator | 50 pregnant women will receive lactoferrin 100 twice daily orally . Receives: Drug: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin
estimation serum ferritin level
Measured: 4 weeks
evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin
estimation hemoglobin level
Measured: 4 weeks
Secondary outcomes (2)
evaluation of lactoferrin side effect
assessment of the incidence rate of nausea, vomiting and GIT upset
Measured: 4 weeks
the incidence rate of constipation
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 posted27 Jun 2023
- Study start30 Jul 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective,randomized,open-label,parallel-group study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal A. Elkholy, Ain Shams University
- Investigators
- Nagwa Sabri, professor, Study chair, Department of Clinical Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921968
- Sponsor's protocol ID
- Lactoferrin in Anemia
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Artym J, Zimecki M, Kruzel ML. Lactoferrin for Prevention and Treatment of Anemia and Inflammation in Pregnant Women: A Comprehensive Review. Biomedicines. 2021 Jul 27;9(8):898. doi: 10.3390/biomedicines9080898.
PubMed 34440102
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy
- ClinicalTrials.gov ID
- NCT05921968
- Acronym / sponsor ID
- Lactoferrin in Anemia
- Conditions
- Iron Deficiency Anemia
- Keywords
- Anemia in pregnancy, Lactoferrin, Iron Sucrose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 27 Jun 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.
Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy.
Detailed description
Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy.
The study will include 100 pregnant women with moderate iron deficiency anemia. They will assigned randomly in to 2 groups. Each group will contain 50 patients.
The first group will receive intravenous iron sucrose (sacrofer 100mg/5ml)as 200 mg elemental iron in 100 ml 0.9 NaCl over 20-30 minutes up to the total dose -Total dose will be calculated from this equation=weight(kg)x(target Hb in g/dl-actual Hb in g/dl)x2.4+500 rounded up to the nearest multiple of 100 mg The second group will receive lactoferrin 100 mg twice daily orally before breakfast and before dinner (pravotin 100 mg sachets will be dissolved in ¼ glass of water). Patients will be advised to avoid coffee, milk products and antacid before and after the dose of lactoferrin.
- Baseline assessment:
All women in the study will be submitted to:
- Complete History Taking Including:
- Personal history: This included name, age, duration of marriage, last menstrual period, parity, occupation and special habits.
- 1st day of last menstrual period.
- Estimated gestational age
- Contraceptive history
- Obstetric history Including:
- Full details of previous pregnancies (Date, outcome, onset and mode of delivery, gestational age at delivery and any associated complication or history of similar disorder, spacing between each pregnancy.
- General Examination Included: Weight, height, body Mass Index (BMI), temperature, pulse, blood pressure, chest and cardiac examination, signs of anemia
- Abdominal Examination
- Fetal monitoring: To confirm fetal maturity and fetal wellbeing by non-stress test and biophysical profile.
- U/S investigation: To confirm gestational age and exclude associated congenital anomalies.
Investigations:
- Complete blood sample (CBC), total iron binding capacity and Transferrin saturation will be done in Ain Shams Maternity Hospital Labs.
- Serum ferritin will be sent to any private lab.
- Kidney function tests and liver function tests. 2. Follow up assessment:
- Anemic pregnant women will be followed up every 4 weeks until delivery.
- In between visits, patients will be contacted via phone for monitoring of any side effects.
- End of study assessment:
- the same laboratory tests will be done with monitoring of any signs or symptoms of anemia until Hb level > 11 g/dl
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective,randomized,open-label,parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Intravenous Iron Sucrose group | Active comparator | Drug: Intravenous iron sucrose50 pregnant women will receive 200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose -The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg |
| Lactoferrin group | Active comparator | Drug: Lactoferrin50 pregnant women will receive lactoferrin 100 twice daily orally . |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women with iron deficiency anemia.
- Microcytic hypochromic anemia, moderate anemia (Hb 8 to 9.9 g/dl) and S. Ferritin levels <12 ng/dl as per WHO guidelines
- Gestational age: - 13-26 weeks.
- Singleton viable pregnancy
- Lastly, agreement to participate and sign the informed consent was a basic prerequisite
Key exclusion criteria (5 listed)
- Women with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemia trait).
- Severe anemia <7 g/dl requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities.
- History of peptic ulcer.
- Hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry.
- Suspected acute infection.
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 |
|---|---|---|
| Intravenous iron sucroseAlso: Intravenous iron sucrose(Sacrofer 100mg/5ml) was manufactured by Amoun company for pharmaceutical and chemical industry ,Egypt.200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose) o The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\dL - actual Hb in g\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg | Drug | Intravenous Iron Sucrose group |
| LactoferrinAlso: lactoferrin 100 mg (Pravotin100 mg sachet)was manufactured by Hygint company for pharmaceutical and chemical industry,Egypt. Egypt) twice daily orally .100 mg twice daily orally before breakfast and dinner | Drug | Lactoferrin group |
Primary outcome
evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin
Time frame: 4 weeks
estimation serum ferritin level
evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin
Time frame: 4 weeks
estimation hemoglobin level
2 secondary outcomes
evaluation of lactoferrin side effect
Time frame: 4 weeks
the incidence rate of constipation
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 19 Jul 2023.
- Background: PubMed 34440102Artym J, Zimecki M, Kruzel ML. Lactoferrin for Prevention and Treatment of Anemia and Inflammation in Pregnant Women: A Comprehensive Review. Biomedicines. 2021 Jul 27;9(8):898. doi: 10.3390/biomedicines9080898.
- Individual participant dataSharing planned: No
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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.
Nagwa Sabri, professor study chair
Department of Clinical Pharmacy
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous iron sucrose and Lactoferrin in people with Iron Deficiency Anemia, run by Ain Shams 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 5 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 19 Jul 2023. 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. 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 Amal Elkholy, PhD (+201060355448, amalanas9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT05921968, which also lists 1 linked publication.
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 19 Jul 2023.