Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency AnemiaPhase 4NCT06252103
Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
A Phase 4 study testing Ferrous Gluconate 300 MG and ferrous gluconate with lactoferrin in people with Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Study Procedures: All patients will undergo the following: Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations. 1. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia
- What is being tested?
- Ferrous Gluconate 300 MG and ferrous gluconate with lactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2023to 30 Dec 2023
- 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 single fetus
- Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl)
- Gestational age (14 - 35 weeks)
- Serum ferritin level \<24 ng/dl
Who cannot join
- Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
- Associated bleeding disorder
- Anaemia requiring blood tranfusion (Hb \< 7gm/dL)
- Hypersensitivity to iron preparations
- Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
Trial locations and contacts
1 site in 1 country.
About this study
Study Procedures:
All patients will undergo the following:
Read more
Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.
- History taking:
- Personal history: name, age, occupation and address.
- Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
- Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.
- Medical examination:
- General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
- Abdominal examination to assess fundal height.
- Investigations to perform will include:
Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.
Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
Read the detailed description
This study included two groups:
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
- Being tested
- Ferrous Gluconate 300 MG, ferrous gluconate with lactoferrin
- Keywords
- iron deficiency anemia during pregnancy, ferrous gluconate, lactoferrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Gluconate 300 MGDrug
Also called (Ferrous-Gluconate®, tab.300mg glucofer, Egypt
iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day
ferrous gluconate with lactoferrinDrug
Also called Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | the first group 20 patients will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. Receives: Drug: Ferrous Gluconate 300 MG |
| group II | Active comparator | 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules. Receives: Drug: ferrous gluconate with lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Hemoglobin (Hb) level
hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl)
Measured: 4 weeks
serum ferritin
serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l )
Measured: 4 weeks
Secondary outcomes (1)
gastrointestinal side effects
(nausea , vomiting , constipation ) will be assessed before and after treatment
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 posted9 Feb 2024
- Study start30 May 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of 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
- Total 40 females from 14 to 35 weeks of pregnancy with Hemoglobin level between 8.5 to 10.5 gm/dl, recruited from the obstetric inpatient/outpatient clinic at Ain Shams University, Maternity hospital. This study included two groups: Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily. hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AMR Saad, doctoral, Study director, faculty of medicine Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252103
- Sponsor's protocol ID
- FMASU MS298/2023
- Status last verified
- May 2023
- First submitted
- 22 Jan 2024
- Last updated
- 9 Feb 2024
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
- ClinicalTrials.gov ID
- NCT06252103
- Acronym / sponsor ID
- FMASU MS298/2023
- Keywords
- iron deficiency anemia during pregnancy, ferrous gluconate, lactoferrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 9 Feb 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.
Study Procedures:
All patients will undergo the following:
Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.
- History taking:
- Personal history: name, age, occupation and address.
- Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.
- Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.
- Medical examination:
- General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)
- Abdominal examination to assess fundal height.
- Investigations to perform will include:
Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.
Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.
Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
Detailed description
This study included two groups:
Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.
Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.
hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total 40 females from 14 to 35 weeks of pregnancy with Hemoglobin level between 8.5 to 10.5 gm/dl, recruited from the obstetric inpatient/outpatient clinic at Ain Shams University, Maternity hospital. This study included two groups: Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily. hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: Ferrous Gluconate 300 MGthe first group 20 patients will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. |
| group II | Active comparator | Drug: ferrous gluconate with lactoferrin20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with single fetus
- Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl)
- Gestational age (14 - 35 weeks)
- Serum ferritin level \<24 ng/dl
Key exclusion criteria (5 listed)
- Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
- Associated bleeding disorder
- Anaemia requiring blood tranfusion (Hb \< 7gm/dL)
- Hypersensitivity to iron preparations
- Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
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 |
|---|---|---|
| Ferrous Gluconate 300 MGAlso: (Ferrous-Gluconate®, tab.300mg glucofer, Egyptiron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day | Drug | group I |
| ferrous gluconate with lactoferrinAlso: Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk | Drug | group II |
Primary outcome
• Hemoglobin (Hb) level
Time frame: 4 weeks
hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl)
serum ferritin
Time frame: 4 weeks
serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l )
1 secondary outcome
gastrointestinal side effects
Time frame: 4 weeks
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 9 Feb 2024.
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.
AMR Saad, doctoral study director
faculty of medicine Ain shams 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 Ferrous Gluconate 300 MG and ferrous gluconate with lactoferrin in people with Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia, 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 4 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: finished, as of the sponsor's last update on 9 Feb 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.
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?
• Hemoglobin (Hb) level (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?
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 9 Feb 2024.