Anemia, Iron DeficiencyPhase 4NCT04435574
Lactoferrin for Treatment of Iron Deficiency Anemia.
A Phase 4 study testing Lactoferrin and Ferrous Sulfate in people with Anemia, Iron Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
Anemia is a great public health problem affecting both developing and developed countries. Iron deficiency anemia represents about 50% of causes of anemia worldwide. Lactoferrin fortified milk has a positive effect on Hb and iron status of infants. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Lactoferrin and Ferrous Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2018to 1 Apr 2019
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with iron deficiency anemia.
Who cannot join
- Malabsorption diseases as coeliac disease.
- Diseases causing chronic blood loss as Meckel diverticulum.
- Documented history of allergy to lactoferrin or ferrous sulfate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Lactoferrin vs Traditional Iron Therapy for Treatment of Iron Deficiency Anemia in School-age Children.
Anemia is a great public health problem affecting both developing and developed countries. Iron deficiency anemia represents about 50% of causes of anemia worldwide.
Lactoferrin fortified milk has a positive effect on Hb and iron status of infants.
the hypothesis of this study is "lactoferrin may have comparable efficacy to ferrous sulfate therapy with more tolerability and fewer side effects".
the research question of this study is whether oral lactoferrin is effective for treatment of iron deficiency anemia, compared to traditional ferrous sulfate therapy regarding hemoglobin rise and side effects and tolerability.
Read the detailed description
Anemia is a great public health problem affecting both developing and developed countries. It is considered the most prevalent form of malnutrition in children and adolescents.
Supplementation with standard iron therapy is the main treatment of iron deficiency anemia.
There are two types of iron that are available: ferric and ferrous iron but ferrous iron better in absorption so it is more common in use.
Three types of ferrous iron are present: ferrous sulfate, ferrous fumarate, and ferrous gluconate but all forms have annoying gastrointestinal side effects including diarrhea, anorexia, heartburn, vomiting, nausea, abdominal cramps, upset stomach, and constipation making continuation on it for many weeks unpleasant for all even adults.
Studies have been performed to explore the effect of oral bovine lactoferrin on iron absorption on pregnant women. Many studies showed that oral bovine lactoferrin for pregnant women increased levels of hemoglobin, total serum iron, and ferritin and decreased the prevalence of iron deficiency anemia. although ferrous sulfate and lactoferrin both of them significantly improve the body's iron stores to the same extent, gastrointestinal side effects of lactoferrin were extremely lower than that of ferrous sulfate so oral bovine lactoferrin can replace iron forms in the treatment of iron deficiency anemia in pregnancy.
Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids. It is a component of exocrine secretions such as milk and saliva and is present in neutrophil granules. Lactoferrin was identified in 1939 in bovine milk and isolated in 1960 from both human and bovine milk. Human colostrum shows the highest levels of lactoferrin while mature milk and other secretions present lower.
Lactoferrin was used in children as antimicrobial in cases of acute diarrhea.In vitro data document the growth inhibition of the diarrheal associated organisms: rotavirus, cholera, salmonella, and shigella by human lactoferrin.
Studies about Milk formula fortified with bovine lactoferrin confirmed its positive effect on Hb and iron status of infants. Recombinant human lactoferrin was extracted from rice seed, is used by Ventria Bioscience as a dietary supplement for treatment of iron of deficiency anemia.
Rationale:
Iron deficiency anemia has a high prevalence rate in scholar age children with their big need to iron for anabolic processes of growth. Supplementation with standard iron therapy is the main treatment however its unpleasant side effects negatively affect patient compliance.
Hypothesis:
Lactoferrin may have a positive effect in the treatment of iron deficiency anemia in school-age children. Lactoferrin side effects less than standard iron therapy.
Research question:
Is lactoferrin usage in the treatment of iron deficiency anemia in scholar age children has a positive effect and little side effects in comparison with standard iron therapy (ferrous sulfate)?.
- Objectives
This study aims to:
- Evaluation of the effect of oral lactoferrin in the treatment of iron deficiency anemia in school-age children in comparison with standard iron therapy (ferrous sulfate).
- Assessment of side effects occurs with the usage of lactoferrin.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Lactoferrin, Ferrous Sulfate
- 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.
LactoferrinDrug
Bovine Lactoferrin 100mg sachets.
Ferrous SulfateDrug
6mg/kg of ferrous sulfate.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | group A is lactoferrin group, receiving 100mg sachet of lactoferrin once daily. Receives: Drug: Lactoferrin |
| Group b | Active comparator | group B is the ferrous sulfate group, receiving 6mg/kg/ day single dose of ferrous sulfate. Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
hemoglobin%
Measured: 8 weeks
Total serum iron
Total serum iron
Measured: 8 weeks
Secondary outcomes (1)
Side effects profile
Score of side effects
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 posted17 Jun 2020
- Study start5 Sep 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single group
- Model description
- the population for the study will be Scholar age Children attend family medicine clinic for treatment of iron deficiency anemia and their parents accept participation in the study. For confirmation of the diagnosis of iron deficiency anemia the following investigations will be done: * CBC * Serum total iron full medical history and examination will be performed. study participants will be assigned to either group A (lactoferrin group) or group B (ferrous sulfate group), and will receive the corresponding medication for 8 weeks. 4 weeks follow up for side effects and hemoglobin level and 8 weeks follow up for side effects, hemoglobin level and serum iron will be performed.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeed Salah Abduljalil Soliman, Cairo University
- Investigators
- Ghada Khfaji, Associate professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435574
- Sponsor's protocol ID
- 70777
- Status last verified
- Jun 2020
- First submitted
- 31 Aug 2018
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stoltzfus R. Defining iron-deficiency anemia in public health terms: a time for reflection. J Nutr. 2001 Feb;131(2S-2):565S-567S. doi: 10.1093/jn/131.2.565S.
PubMed 11160589Paesano R, Torcia F, Berlutti F, Pacifici E, Ebano V, Moscarini M, Valenti P. Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant women. Biochem Cell Biol. 2006 Jun;84(3):377-80. doi: 10.1139/o06-040.
PubMed 16936810Paesano R, Pietropaoli M, Gessani S, Valenti P. The influence of lactoferrin, orally administered, on systemic iron homeostasis in pregnant women suffering of iron deficiency and iron deficiency anaemia. Biochimie. 2009 Jan;91(1):44-51. doi: 10.1016/j.biochi.2008.06.004. Epub 2008 Jun 14.
PubMed 18601971Rezk M, Dawood R, Abo-Elnasr M, Al Halaby A, Marawan H. Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Fetal Neonatal Med. 2016;29(9):1387-90. doi: 10.3109/14767058.2015.1049149. Epub 2015 Jun 3.
PubMed 26037728
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lactoferrin vs Traditional Iron Therapy for Treatment of Iron Deficiency Anemia in School-age Children.
- ClinicalTrials.gov ID
- NCT04435574
- Acronym / sponsor ID
- 70777
- Conditions
- Anemia, Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 17 Jun 2020 (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.
Anemia is a great public health problem affecting both developing and developed countries. Iron deficiency anemia represents about 50% of causes of anemia worldwide.
Lactoferrin fortified milk has a positive effect on Hb and iron status of infants.
the hypothesis of this study is "lactoferrin may have comparable efficacy to ferrous sulfate therapy with more tolerability and fewer side effects".
the research question of this study is whether oral lactoferrin is effective for treatment of iron deficiency anemia, compared to traditional ferrous sulfate therapy regarding hemoglobin rise and side effects and tolerability.
Detailed description
Anemia is a great public health problem affecting both developing and developed countries. It is considered the most prevalent form of malnutrition in children and adolescents.
Supplementation with standard iron therapy is the main treatment of iron deficiency anemia.
There are two types of iron that are available: ferric and ferrous iron but ferrous iron better in absorption so it is more common in use.
Three types of ferrous iron are present: ferrous sulfate, ferrous fumarate, and ferrous gluconate but all forms have annoying gastrointestinal side effects including diarrhea, anorexia, heartburn, vomiting, nausea, abdominal cramps, upset stomach, and constipation making continuation on it for many weeks unpleasant for all even adults.
Studies have been performed to explore the effect of oral bovine lactoferrin on iron absorption on pregnant women. Many studies showed that oral bovine lactoferrin for pregnant women increased levels of hemoglobin, total serum iron, and ferritin and decreased the prevalence of iron deficiency anemia. although ferrous sulfate and lactoferrin both of them significantly improve the body's iron stores to the same extent, gastrointestinal side effects of lactoferrin were extremely lower than that of ferrous sulfate so oral bovine lactoferrin can replace iron forms in the treatment of iron deficiency anemia in pregnancy.
Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids. It is a component of exocrine secretions such as milk and saliva and is present in neutrophil granules. Lactoferrin was identified in 1939 in bovine milk and isolated in 1960 from both human and bovine milk. Human colostrum shows the highest levels of lactoferrin while mature milk and other secretions present lower.
Lactoferrin was used in children as antimicrobial in cases of acute diarrhea.In vitro data document the growth inhibition of the diarrheal associated organisms: rotavirus, cholera, salmonella, and shigella by human lactoferrin.
Studies about Milk formula fortified with bovine lactoferrin confirmed its positive effect on Hb and iron status of infants. Recombinant human lactoferrin was extracted from rice seed, is used by Ventria Bioscience as a dietary supplement for treatment of iron of deficiency anemia.
Rationale:
Iron deficiency anemia has a high prevalence rate in scholar age children with their big need to iron for anabolic processes of growth. Supplementation with standard iron therapy is the main treatment however its unpleasant side effects negatively affect patient compliance.
Hypothesis:
Lactoferrin may have a positive effect in the treatment of iron deficiency anemia in school-age children. Lactoferrin side effects less than standard iron therapy.
Research question:
Is lactoferrin usage in the treatment of iron deficiency anemia in scholar age children has a positive effect and little side effects in comparison with standard iron therapy (ferrous sulfate)?.
- Objectives
This study aims to:
- Evaluation of the effect of oral lactoferrin in the treatment of iron deficiency anemia in school-age children in comparison with standard iron therapy (ferrous sulfate).
- Assessment of side effects occurs with the usage of lactoferrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the population for the study will be Scholar age Children attend family medicine clinic for treatment of iron deficiency anemia and their parents accept participation in the study. For confirmation of the diagnosis of iron deficiency anemia the following investigations will be done: * CBC * Serum total iron full medical history and examination will be performed. study participants will be assigned to either group A (lactoferrin group) or group B (ferrous sulfate group), and will receive the corresponding medication for 8 weeks. 4 weeks follow up for side effects and hemoglobin level and 8 weeks follow up for side effects, hemoglobin level and serum iron will be performed.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Lactoferringroup A is lactoferrin group, receiving 100mg sachet of lactoferrin once daily. |
| Group b | Active comparator | Drug: Ferrous Sulfategroup B is the ferrous sulfate group, receiving 6mg/kg/ day single dose of ferrous sulfate. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with iron deficiency anemia.
Key exclusion criteria (3 listed)
- Malabsorption diseases as coeliac disease.
- Diseases causing chronic blood loss as Meckel diverticulum.
- Documented history of allergy to lactoferrin or ferrous sulfate.
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 |
|---|---|---|
| LactoferrinBovine Lactoferrin 100mg sachets. | Drug | Group A |
| Ferrous Sulfate6mg/kg of ferrous sulfate. | Drug | Group b |
Primary outcome
Hemoglobin
Time frame: 8 weeks
hemoglobin%
Total serum iron
Time frame: 8 weeks
Total serum iron
1 secondary outcome
Side effects profile
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 17 Jun 2020.
- Background: PubMed 11160589Stoltzfus R. Defining iron-deficiency anemia in public health terms: a time for reflection. J Nutr. 2001 Feb;131(2S-2):565S-567S. doi: 10.1093/jn/131.2.565S.
- Background: PubMed 16936810Paesano R, Torcia F, Berlutti F, Pacifici E, Ebano V, Moscarini M, Valenti P. Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant women. Biochem Cell Biol. 2006 Jun;84(3):377-80. doi: 10.1139/o06-040.
- Background: PubMed 18601971Paesano R, Pietropaoli M, Gessani S, Valenti P. The influence of lactoferrin, orally administered, on systemic iron homeostasis in pregnant women suffering of iron deficiency and iron deficiency anaemia. Biochimie. 2009 Jan;91(1):44-51. doi: 10.1016/j.biochi.2008.06.004. Epub 2008 Jun 14.
- Background: PubMed 26037728Rezk M, Dawood R, Abo-Elnasr M, Al Halaby A, Marawan H. Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Fetal Neonatal Med. 2016;29(9):1387-90. doi: 10.3109/14767058.2015.1049149. Epub 2015 Jun 3.
- 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.
Ghada Khfaji, Associate professor principal investigator
Cairo 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 Lactoferrin and Ferrous Sulfate in people with Anemia, Iron Deficiency, run by Cairo 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 1 inclusion and 3 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 17 Jun 2020. 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 (time frame: 8 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?
On the ClinicalTrials.gov record for NCT04435574, which also lists 4 linked publications.
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 17 Jun 2020.