Iron Deficiency AnemiaNCT06590831
Lactoferrin Alone ,Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia
A study testing Lactoferrin in people with Iron Deficiency Anemia, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Iron deficiency (ID) and iron deficiency anemia (IDA) are the most common iron disorders throughout the world. ID and IDA, particularly caused by increased iron requirements during pregnancy; represent a high risk for preterm delivery, fetal growth retardation, low birth weight, and inferior neonatal health. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Lactoferrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 10 Jun 2024
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with single fetus
- All pregnant women in 3rd trimester (28w_36w) complaining of mild IDA
- Iron Deficiency Anemia mild anemia (hemoglobin level < 11 mg/dl , and serum ferritin level < 12 mg/dl).
Who cannot join
- Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia.
- Clinical and/or laboratory evidence of hepatic, renal, cardiovascular abnormalities.
- History of peptic disorders.
- Esophagitis
- Hiatal hernia
- Malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactoferrin Alone ,Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia During the 3rd Trimester of Pregnancy (Randomized Controlled Trial)
Iron deficiency (ID) and iron deficiency anemia (IDA) are the most common iron disorders throughout the world.
ID and IDA, particularly caused by increased iron requirements during pregnancy; represent a high risk for preterm delivery, fetal growth retardation, low birth weight, and inferior neonatal health. These pregnancy complications are thought to occur because of an increased iron requirement, related to enhanced blood volume and development of the fetoplacental unit.
Read the detailed description
The World Health Organization (WHO) defines anemia in pregnancy as a hemoglobin (Hb) concentration of < 11 g/dl. Centers for disease control \&prevention determine a cut of -off point 10.5 g/dl during 2nd trimester for diagnosis of IDA.
Iron deficiency anemia (IDA) is the most common type of anemia in pregnancy. The iron content of the body is normally kept constant by regulating the amount absorbed to balance the amount lost.
The WHO estimates that 46% of pregnant women in African region, 38% in Eastern Mediterranean region, 25% in European region and 24% in the region of the Americas are anemic mainly because of iron deficiency. Anemia is a common medical disorder affecting a lot of women in pregnancy in the developing countries.
Management of anemia remain an important issue in prenatal medicine. Correct diagnosis and treatment lead to effective management of fetal and maternal risk and improved prenatal outcome. Diet alone can't supply the 30-40 mg iron that is required for absorption of 4-6mg iron per day needed during the later stage of pregnancy so iron supplementation is strongly recommended for all females in developing countries.
Traditional therapeutic options of iron deficiency anemia during pregnancy were administration of oral iron shows lack of compliance and side effects and often limited intestinal absorption and bioavailability. The most used treatment for ID and IDA currently consists of oral administration of iron as ferrous sulphate. However, ferrous sulphate administration often fails to exert any significant effects on these pregnancy-associated pathologies, and frequently causes several adverse effects.
This is likely due to the poor bioavailability of inorganic iron requiring the administration of large quantity of ferrous sulphate. Lactoferrin is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions. Lactoferrin is also present in secondary granules of Polymorpho nuclear leucocyte and is secreted by some acinar cells. Lactoferrin can be purified from milk or produced recombinantly .
Lactoferrin (previously lactotransferrin)is a glycoprotein that belongs to transferrin family ,which includes protiens that may bind \&transferrin.Lactoferrin levels in cow milk \&human milk colostrum are roughly seven times higher than lactoferrin levels in milk prouduced later
- Conditions
- Iron Deficiency Anemia
- Being tested
- Lactoferrin
- 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.
LactoferrinDrug
Also called Iron
to compare between efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Group A: (lactoferrin Group) | Active comparator | About 133 anemic pregnant women will be treated with lactoferrin only (pravotin 100mg ) twice daily for 4 weeks. Receives: Drug: Lactoferrin |
| Group B: (Amino acid chelated iron Group) | Active comparator | About 133 anemic pregnant women will be treated with amino acid chelated iron only (phara fero 27) once daily for 4 weeks. Receives: Drug: Lactoferrin |
| Group C: (lactoferrin with amino acid chelated iron Group) | Active comparator | About 133 anemic pregnant women will be treated with lactoferrin with amino acid chelated iron (phara fero 27 plus ) once daily for 4 weeks Receives: Drug: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Anemia
Efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy by measuring the hemoglobin level before and after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Jun 2023
- Primary completion1 Jun 2024
- Study completion10 Jun 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- Ahmed Ali Nasr, Professor, Study chair, Al-Azhar University, Faculty of medicine, Assuit.Medhat kamel fathy, Lecturer, Study director, Al-Azhar University, Faculty of medicine, Assuit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590831
- Sponsor's protocol ID
- Rehab Ahmed Amine
- Status last verified
- Jun 2023
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin Alone ,Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia During the 3rd Trimester of Pregnancy (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06590831
- Acronym / sponsor ID
- Rehab Ahmed Amine
- Conditions
- Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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 (ID) and iron deficiency anemia (IDA) are the most common iron disorders throughout the world.
ID and IDA, particularly caused by increased iron requirements during pregnancy; represent a high risk for preterm delivery, fetal growth retardation, low birth weight, and inferior neonatal health. These pregnancy complications are thought to occur because of an increased iron requirement, related to enhanced blood volume and development of the fetoplacental unit.
Detailed description
The World Health Organization (WHO) defines anemia in pregnancy as a hemoglobin (Hb) concentration of < 11 g/dl. Centers for disease control \&prevention determine a cut of -off point 10.5 g/dl during 2nd trimester for diagnosis of IDA.
Iron deficiency anemia (IDA) is the most common type of anemia in pregnancy. The iron content of the body is normally kept constant by regulating the amount absorbed to balance the amount lost.
The WHO estimates that 46% of pregnant women in African region, 38% in Eastern Mediterranean region, 25% in European region and 24% in the region of the Americas are anemic mainly because of iron deficiency. Anemia is a common medical disorder affecting a lot of women in pregnancy in the developing countries.
Management of anemia remain an important issue in prenatal medicine. Correct diagnosis and treatment lead to effective management of fetal and maternal risk and improved prenatal outcome. Diet alone can't supply the 30-40 mg iron that is required for absorption of 4-6mg iron per day needed during the later stage of pregnancy so iron supplementation is strongly recommended for all females in developing countries.
Traditional therapeutic options of iron deficiency anemia during pregnancy were administration of oral iron shows lack of compliance and side effects and often limited intestinal absorption and bioavailability. The most used treatment for ID and IDA currently consists of oral administration of iron as ferrous sulphate. However, ferrous sulphate administration often fails to exert any significant effects on these pregnancy-associated pathologies, and frequently causes several adverse effects.
This is likely due to the poor bioavailability of inorganic iron requiring the administration of large quantity of ferrous sulphate. Lactoferrin is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions. Lactoferrin is also present in secondary granules of Polymorpho nuclear leucocyte and is secreted by some acinar cells. Lactoferrin can be purified from milk or produced recombinantly .
Lactoferrin (previously lactotransferrin)is a glycoprotein that belongs to transferrin family ,which includes protiens that may bind \&transferrin.Lactoferrin levels in cow milk \&human milk colostrum are roughly seven times higher than lactoferrin levels in milk prouduced later
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: (lactoferrin Group) | Active comparator | Drug: LactoferrinAbout 133 anemic pregnant women will be treated with lactoferrin only (pravotin 100mg ) twice daily for 4 weeks. |
| Group B: (Amino acid chelated iron Group) | Active comparator | Drug: LactoferrinAbout 133 anemic pregnant women will be treated with amino acid chelated iron only (phara fero 27) once daily for 4 weeks. |
| Group C: (lactoferrin with amino acid chelated iron Group) | Active comparator | Drug: LactoferrinAbout 133 anemic pregnant women will be treated with lactoferrin with amino acid chelated iron (phara fero 27 plus ) once daily for 4 weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women with single fetus
- All pregnant women in 3rd trimester (28w_36w) complaining of mild IDA
- Iron Deficiency Anemia mild anemia (hemoglobin level < 11 mg/dl , and serum ferritin level < 12 mg/dl).
Key exclusion criteria (6 listed)
- Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia.
- Clinical and/or laboratory evidence of hepatic, renal, cardiovascular abnormalities.
- History of peptic disorders.
- Esophagitis
- Hiatal hernia
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 |
|---|---|---|
| LactoferrinAlso: Ironto compare between efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy | Drug | Group A: (lactoferrin Group), Group B: (Amino acid chelated iron Group), Group C: (lactoferrin with amino acid chelated iron Group) |
Primary outcome
Treatment of Anemia
Time frame: 6 months
Efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy by measuring the hemoglobin level before and after treatment
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 19 Sep 2024.
- 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.
Ahmed Ali Nasr, Professor study chair
Al-Azhar University, Faculty of medicine, Assuit.
Medhat kamel fathy, Lecturer study director
Al-Azhar University, Faculty of medicine, Assuit.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin in people with Iron Deficiency Anemia, run by Egymedicalpedia 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 3 inclusion and 6 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 19 Sep 2024. 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.
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?
Treatment of Anemia (time frame: 6 months). 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 19 Sep 2024.