Anemia During PregnancyPhase 4NCT03202615
Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
A Phase 4 study testing L (lactoferrin) and F (ferrous sulphate) in people with Anemia During Pregnancy, run by Abdelwahed, Mai Mahmoud Mohamed, M.D. at 1 site in Egypt.
Trial summary
130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Anemia During Pregnancy
- What is being tested?
- L (lactoferrin) and F (ferrous sulphate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Oct 2018
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant with singleton intrauterine pregnancy
- 14- 20 weeks of gestation
- Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.
Who cannot join
- Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait).
- Hemoglobin less than 9 g/dL.
- Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
- History of acid-peptic disorders, esophagitis, or hiatal hernia.
- Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
- Medical disorders with pregnancy.
Show all 11Show fewer
- Bleeding in early pregnancy.
- Allergies to milk proteins / hypersensitivity to iron preparations.
- History of ingestion of any hematinics within the last 1 month before study entry.
- Recent blood transfusion.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Gihan E El Hawwary, specialist contact
Egypt1 site, 1 recruiting
- Recruiting
Mai Mahmoud Mohamed
Alexandria, 12345
Mai Ms Abdelwahed, Master, 01152684127 ext. 002, maya_mohamed0@hotmail.com
Sherif Mr Ashoush, Doctoral, 01222660266 ext. 002, sherifashoush@hotmail.com
About this study
Official title: Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial
130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.
Read the detailed description
The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.
- Conditions
- Anemia During Pregnancy
- Being tested
- L (lactoferrin), F (ferrous sulphate)
- Keywords
- lactoferrin, iron deficiency anemia in pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L (lactoferrin)Dietary supplement
Also called Pravotin sachets
Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets
F (ferrous sulphate)Drug
Also called Ferrofol capsules
Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.
| Study group | Role | What they receive |
|---|---|---|
| L (lactoferrin in IDA with pregnancy) | Experimental | Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach. Receives: Dietary Supplement: L (lactoferrin) |
| F (ferrous sulphate with pregnancy) | Active comparator | Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day. Receives: Drug: F (ferrous sulphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Hemoglobin concentration
grams/dL
Measured: At time 0 (enrollment),1 and 2 months
Secondary outcomes (7)
Serum ferritin
nanograms per milliliter
Measured: At time 0 (enrollment) and 2 months
mean cell volume (MCV)
fL/red cell in adult
Measured: At time 0 (enrollment) and 2 months
mean corpuscular hemoglobin (MCH)
picograms (pg)/cell in adults
Measured: At time 0 (enrollment) and 2 months
mean cell hemoglobin concentration (MCHC)
g/dL
Measured: At time 0 (enrollment) and 2 months
cost
The average drug cost by LE.
Measured: 1-2 months
percentage of women who agree to take each of the two drugs for a future whole pregnancy.
percentage
Measured: At time 0 (enrollment) and every 2 weeks, for 2 months
Side effects:
scaling score of side effects of oral administration of bLf and ferrous sulfate as:
- gastrointestinal discomfort
- nausea
- heart burn
- constipation The degree of side effects will be assessed using objective scaling scoring system: 0 (no symptoms), 1 (mild not requiring any change in life style), 2 (severe controlled with another method), 3 (severe not controlled but accepting), 4 (severe not controlled and not accepting).
Measured: At time 0 (enrollment) and every 2 weeks, for 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startSep 2015
- Primary completionAug 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia During 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelwahed, Mai Mahmoud Mohamed, M.D.
- Responsible party
- Sponsor
- Investigators
- Sherif A Ashoush, a. professor, Study chair, personal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202615
- Sponsor's protocol ID
- AbdelwahedM
- Other IDs
- AshoushS, IbrahimK, ElhawariG
- Status last verified
- Jul 2018
- First submitted
- 6 Dec 2015
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03202615
- Acronym / sponsor ID
- AbdelwahedM
- Conditions
- Anemia During Pregnancy
- Keywords
- lactoferrin, iron deficiency anemia in pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Abdelwahed, Mai Mahmoud Mohamed, M.D.
- Study start
- Sep 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 28 Jun 2017 (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.
130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.
Detailed description
The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L (lactoferrin in IDA with pregnancy) | Experimental | Dietary Supplement: L (lactoferrin)Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach. |
| F (ferrous sulphate with pregnancy) | Active comparator | Drug: F (ferrous sulphate)Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant with singleton intrauterine pregnancy
- 14- 20 weeks of gestation
- Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.
Key exclusion criteria (11 listed)
- Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait).
- Hemoglobin less than 9 g/dL.
- Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
- History of acid-peptic disorders, esophagitis, or hiatal hernia.
- Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
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 |
|---|---|---|
| L (lactoferrin)Also: Pravotin sachetsDietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets | Dietary supplement | L (lactoferrin in IDA with pregnancy) |
| F (ferrous sulphate)Also: Ferrofol capsulesDrug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets. | Drug | F (ferrous sulphate with pregnancy) |
Primary outcome
change in Hemoglobin concentration
Time frame: At time 0 (enrollment),1 and 2 months
grams/dL
7 secondary outcomes
Serum ferritin
Time frame: At time 0 (enrollment) and 2 months
mean cell volume (MCV)
Time frame: At time 0 (enrollment) and 2 months
mean corpuscular hemoglobin (MCH)
Time frame: At time 0 (enrollment) and 2 months
mean cell hemoglobin concentration (MCHC)
Time frame: At time 0 (enrollment) and 2 months
cost
Time frame: 1-2 months
percentage of women who agree to take each of the two drugs for a future whole pregnancy.
Time frame: At time 0 (enrollment) and every 2 weeks, for 2 months
Side effects:
Time frame: At time 0 (enrollment) and every 2 weeks, for 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Gihan E El Hawwary, specialist contact
Sherif A Ashoush, a. professor study chair
personal
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 L (lactoferrin) and F (ferrous sulphate) in people with Anemia During Pregnancy, run by Abdelwahed, Mai Mahmoud Mohamed, M.D. 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 11 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 9 Jul 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 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 Mai M Abdelwahed, specialist (01152684127 ext. 002, maya_mohamed0@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Hemoglobin concentration (time frame: At time 0 (enrollment),1 and 2 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 9 Jul 2018.