Iron Deficiency Anemia of PregnancyPhase 1/2NCT03484845
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
A Phase 1/2 study testing Lactoferrin and ferrous fumarate in people with Iron Deficiency Anemia of Pregnancy, run by Assiut University.
Trial summary
This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Lactoferrin and ferrous fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Dec 2019
- Phase
- Phase 1/2
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women from 24-36 weeks of gestation.
- Mild to moderate anemia.
Who cannot join
- Women with a history of anemia due to any other causes other than IDA.
- Severe anemia requiring blood transfusion.
- History of peptic ulcer.
- known hypersensitivity to iron preparations.
Trial locations and contacts
No sites are listed yet.
About this study
This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.
Read the detailed description
Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type 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 daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Lactoferrin and ferrous fumarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin and ferrous fumarateDrug
Also called pravotin sachets and vitayami tablets
- Group 1:include 50 women will receive oral lactoferrin 100mg twice daily .
- Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily .
- Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily .
| Study group | Role | What they receive |
|---|---|---|
| Oral lactoferrin | Active comparator | women who take oral lactoferrin sachets 100 mg twice daily for one month. Receives: Drug: Lactoferrin and ferrous fumarate |
| Oral ferrous fumarate | Active comparator | women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month. Receives: Drug: Lactoferrin and ferrous fumarate |
| Combined lactoferrin & ferrous fumarate | Active comparator | women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month. Receives: Drug: Lactoferrin and ferrous fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in blood hemoglobin.
mean difference in hemoglobin level between pre treatment and post treatment.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (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 of PregnancyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amaal Khalil Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484845
- Sponsor's protocol ID
- u1111-1210-1436
- Status last verified
- Jun 2018
- First submitted
- 20 Mar 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
- ClinicalTrials.gov ID
- NCT03484845
- Acronym / sponsor ID
- u1111-1210-1436
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 2 Apr 2018 (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.
This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.
Detailed description
Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type 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 daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral lactoferrin | Active comparator | Drug: Lactoferrin and ferrous fumaratewomen who take oral lactoferrin sachets 100 mg twice daily for one month. |
| Oral ferrous fumarate | Active comparator | Drug: Lactoferrin and ferrous fumaratewomen who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month. |
| Combined lactoferrin & ferrous fumarate | Active comparator | Drug: Lactoferrin and ferrous fumaratewomen who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women from 24-36 weeks of gestation.
- Mild to moderate anemia.
Key exclusion criteria (4 listed)
- Women with a history of anemia due to any other causes other than IDA.
- Severe anemia requiring blood transfusion.
- History of peptic ulcer.
- known hypersensitivity to iron preparations.
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 and ferrous fumarateAlso: pravotin sachets and vitayami tablets* Group 1:include 50 women will receive oral lactoferrin 100mg twice daily . * Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily . * Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily . | Drug | Combined lactoferrin & ferrous fumarate, Oral ferrous fumarate, Oral lactoferrin |
Primary outcome
Increase in blood hemoglobin.
Time frame: one month
mean difference in hemoglobin level between pre treatment and post treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactoferrin and ferrous fumarate in people with Iron Deficiency Anemia of Pregnancy, run by Assiut 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 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 2018. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 amaal khalil, master (02201154883113, amaal.moussa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in blood hemoglobin. (time frame: one month). 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 3 Jul 2018.