Iron Deficiency AnemiaPhase 2NCT03759353
Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
A Phase 2 study testing Baseline ferritin level, Lactoferrin and Ferrous Sulfate in people with Iron Deficiency Anemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Baseline ferritin level, Lactoferrin and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 20 Nov 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with single fetus.
- Second trimester (14-20weeks of gestation).
- Normal Hemoglobin level: more than10g\dl.
- Serum ferritin less than 15 mcg / L
Who cannot join
- Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)
- Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.)
- Having hypersensitivity to iron preparations.
- Treatment with any other iron preparation in the last month.
- History of peptic ulcer, oesophagitis or hiatal hernia.
- Medical disorders with pregnancy.
Show all 12Show fewer
- Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
- Bleeding in early pregnancy.
- Refusal to participate in the study.
- Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
- Recent blood transfusion.
- Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.
Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.
This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Baseline ferritin level, Lactoferrin, Ferrous Sulfate, Follow up ferritin level
- 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.
Baseline ferritin levelDiagnostic test
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
LactoferrinDrug
Also called Pravotin
lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
Ferrous SulfateDrug
Also called Feosol
200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.
Follow up ferritin levelDiagnostic test
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin Group | Active comparator | Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment. Receives: Diagnostic Test: Baseline ferritin level; Drug: Lactoferrin; Diagnostic Test: Follow up ferritin level |
| Ferrous Sulfate Group | Active comparator | Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment. Receives: Diagnostic Test: Baseline ferritin level; Drug: Ferrous Sulfate; Diagnostic Test: Follow up ferritin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin level
Change in serum ferritin level between enrollment and 4 weeks post-treatment.
Measured: 4 weeks
Secondary outcomes (3)
Nausea and/or vomiting
Incidence of treatment-related nausea and/or vomiting
Measured: 4 weeks
Dyspepsia
Incidence of treatment-related dyspepsia
Measured: 4 weeks
Compliance to treatment
Number of missed doses of treatment from the assigned 30 doses
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 posted30 Nov 2018
- Study start15 Jan 2018
- Primary completion30 Oct 2018
- Study completion20 Nov 2018
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Ahmed, Ain Shams University
- Investigators
- Ghada Mohamed, MBBCh, Principal investigator, G Darwish
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759353
- Sponsor's protocol ID
- LactvsFerr
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 30 Nov 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 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
- ClinicalTrials.gov ID
- NCT03759353
- Acronym / sponsor ID
- LactvsFerr
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 30 Nov 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.
The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.
Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.
This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 98 pregnant women with iron deficiency will be randomized into two groups: lactoferrin group or ferrous sulfate group
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin Group | Active comparator | Diagnostic Test: Baseline ferritin level, Drug: Lactoferrin, Diagnostic Test: Follow up ferritin levelIncludes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment. |
| Ferrous Sulfate Group | Active comparator | Diagnostic Test: Baseline ferritin level, Drug: Ferrous Sulfate, Diagnostic Test: Follow up ferritin levelIncludes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with single fetus.
- Second trimester (14-20weeks of gestation).
- Normal Hemoglobin level: more than10g\dl.
- Serum ferritin less than 15 mcg / L
Key exclusion criteria (12 listed)
- Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)
- Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.)
- Having hypersensitivity to iron preparations.
- Treatment with any other iron preparation in the last month.
- History of peptic ulcer, oesophagitis or 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 |
|---|---|---|
| Baseline ferritin levelAt enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency. | Diagnostic test | Ferrous Sulfate Group, Lactoferrin Group |
| LactoferrinAlso: Pravotinlactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals). | Drug | Lactoferrin Group |
| Ferrous SulfateAlso: Feosol200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset. | Drug | Ferrous Sulfate Group |
| Follow up ferritin levelFour weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status. | Diagnostic test | Ferrous Sulfate Group, Lactoferrin Group |
Primary outcome
Change in serum ferritin level
Time frame: 4 weeks
Change in serum ferritin level between enrollment and 4 weeks post-treatment.
3 secondary outcomes
Nausea and/or vomiting
Time frame: 4 weeks
Dyspepsia
Time frame: 4 weeks
Compliance to treatment
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 30 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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.
Ghada Mohamed, MBBCh principal investigator
G Darwish
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 Baseline ferritin level, Lactoferrin and Ferrous Sulfate in people with 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 12 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 30 Nov 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?
Change in serum ferritin 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 30 Nov 2018.