Iron Deficiency Anemia of PregnancyPhase 2NCT03481790
Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy
A Phase 2 study testing Lactoferrin and ferrous sulphate + folic acid (vitamin B9) in people with Iron Deficiency Anemia of Pregnancy, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy. Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Lactoferrin and ferrous sulphate + folic acid (vitamin B9)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 5 Mar 2018
- Phase
- Phase 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with single fetus
- Hb count < 11g/dL
- ferritin level < 12 ng/dL
- Gestational age (14 - 30 weeks)
Who cannot join
- Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
- Associated bleeding disorder
- Anaemia requiring blood tranfusion (Hb < 7g/dL)
- Hypersensitivity to iron preparations
- Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia
This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.
Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.
Read the detailed description
Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.
Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.
Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Lactoferrin, ferrous sulphate + folic acid (vitamin B9)
- Keywords
- iron deficiency anemia of pregnancy - lactoferrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDrug
Also called Pravotin, MamyVital
(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.
ferrous sulphate + folic acid (vitamin B9)Drug
Also called Ferrofol
(Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin | Experimental | 100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day. Receives: Drug: Lactoferrin |
| ferrous sulphate + folic acid (vitamin B9) | Experimental | 150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day. Receives: Drug: ferrous sulphate + folic acid (vitamin B9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (Hb) level.
to be measured before and after treatment.
Measured: 4 weeks
Secondary outcomes (1)
serum ferritin level.
to be measured 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 posted29 Mar 2018
- Study start1 Sep 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 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 of PregnancyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Balsha, Ain Shams Maternity Hospital
- Investigators
- Ahmed Mamdouh, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481790
- Sponsor's protocol ID
- AinShams Maternity Hospital
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 29 Mar 2018
- 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 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia
- ClinicalTrials.gov ID
- NCT03481790
- Acronym / sponsor ID
- AinShams Maternity Hospital
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Keywords
- iron deficiency anemia of pregnancy - lactoferrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 29 Mar 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 evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.
Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.
Detailed description
Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.
Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.
Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin | Experimental | Drug: Lactoferrin100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day. |
| ferrous sulphate + folic acid (vitamin B9) | Experimental | Drug: ferrous sulphate + folic acid (vitamin B9)150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with single fetus
- Hb count < 11g/dL
- ferritin level < 12 ng/dL
- Gestational age (14 - 30 weeks)
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 < 7g/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 |
|---|---|---|
| LactoferrinAlso: Pravotin, MamyVital(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks. | Drug | Lactoferrin |
| ferrous sulphate + folic acid (vitamin B9)Also: Ferrofol(Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks. | Drug | ferrous sulphate + folic acid (vitamin B9) |
Primary outcome
Hemoglobin (Hb) level.
Time frame: 4 weeks
to be measured before and after treatment.
1 secondary outcome
serum ferritin level.
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 29 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia of Pregnancy
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
RecruitingPhase 2
Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
Iron Deficiency (ID), Pregnancy
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
RecruitingObservational study
Maternal Iron Deficiency and Childhood Health
Iron Deficiency Anaemia in Childbirth, Iron Deficiency
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 Mamdouh study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactoferrin and ferrous sulphate + folic acid (vitamin B9) in people with Iron Deficiency Anemia of Pregnancy, run by Ain Shams Maternity Hospital 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 29 Mar 2018. 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 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?
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). 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 29 Mar 2018.