Lactoferrin for Treatment of Iron Deficiency Anemia.
Primary Purpose
Anemia, Iron Deficiency
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin
Ferrous Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Iron Deficiency
Eligibility Criteria
Inclusion Criteria:
- Children with iron deficiency anemia.
Exclusion Criteria:
- Malabsorption diseases as coeliac disease.
- Diseases causing chronic blood loss as Meckel diverticulum.
- Documented history of allergy to lactoferrin or ferrous sulfate.
Sites / Locations
- Primary care center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group b
Arm Description
group A is lactoferrin group, receiving 100mg sachet of lactoferrin once daily.
group B is the ferrous sulfate group, receiving 6mg/kg/ day single dose of ferrous sulfate.
Outcomes
Primary Outcome Measures
Hemoglobin
hemoglobin%
Total serum iron
Total serum iron
Secondary Outcome Measures
Side effects profile
Score of side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04435574
Brief Title
Lactoferrin for Treatment of Iron Deficiency Anemia.
Official Title
Comparison of Lactoferrin vs Traditional Iron Therapy for Treatment of Iron Deficiency Anemia in School-age Children.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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)?.
1. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
group A is lactoferrin group, receiving 100mg sachet of lactoferrin once daily.
Arm Title
Group b
Arm Type
Active Comparator
Arm Description
group B is the ferrous sulfate group, receiving 6mg/kg/ day single dose of ferrous sulfate.
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Intervention Description
Bovine Lactoferrin 100mg sachets.
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Intervention Description
6mg/kg of ferrous sulfate.
Primary Outcome Measure Information:
Title
Hemoglobin
Description
hemoglobin%
Time Frame
8 weeks
Title
Total serum iron
Description
Total serum iron
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Side effects profile
Description
Score of side effects
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with iron deficiency anemia.
Exclusion Criteria:
Malabsorption diseases as coeliac disease.
Diseases causing chronic blood loss as Meckel diverticulum.
Documented history of allergy to lactoferrin or ferrous sulfate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada Khfaji, Associate professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary care center
City
Giza
ZIP/Postal Code
12561
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11160589
Citation
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.
Results Reference
background
PubMed Identifier
16936810
Citation
Paesano 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.
Results Reference
background
PubMed Identifier
18601971
Citation
Paesano 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.
Results Reference
background
PubMed Identifier
26037728
Citation
Rezk 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.
Results Reference
background
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Lactoferrin for Treatment of Iron Deficiency Anemia.
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