Back to resultsLactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
Primary Purpose
Iron Deficiency Anemia of Pregnancy
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lactoferrin and ferrous fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women from 24-36 weeks of gestation.
- Mild to moderate anemia.
Exclusion Criteria:
- Women with a history of anemia due to any other causes other than IDA.
- Severe anemia requiring blood transfusion.
- History of peptic ulcer.
- known hypersensitivity to iron preparations.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Oral lactoferrin
Oral ferrous fumarate
Combined lactoferrin & ferrous fumarate
Arm Description
women who take oral lactoferrin sachets 100 mg twice daily for one month.
women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.
women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.
Outcomes
Primary Outcome Measures
Increase in blood hemoglobin.
mean difference in hemoglobin level between pre treatment and post treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03484845
Brief Title
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
Official Title
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.
Detailed Description
Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type of anemia Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral lactoferrin
Arm Type
Active Comparator
Arm Description
women who take oral lactoferrin sachets 100 mg twice daily for one month.
Arm Title
Oral ferrous fumarate
Arm Type
Active Comparator
Arm Description
women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.
Arm Title
Combined lactoferrin & ferrous fumarate
Arm Type
Active Comparator
Arm Description
women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.
Intervention Type
Drug
Intervention Name(s)
Lactoferrin and ferrous fumarate
Other Intervention Name(s)
pravotin sachets and vitayami tablets
Intervention Description
Group 1:include 50 women will receive oral lactoferrin 100mg twice daily .
Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily .
Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily .
Primary Outcome Measure Information:
Title
Increase in blood hemoglobin.
Description
mean difference in hemoglobin level between pre treatment and post treatment.
Time Frame
one month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women from 24-36 weeks of gestation.
Mild to moderate anemia.
Exclusion Criteria:
Women with a history of anemia due to any other causes other than IDA.
Severe anemia requiring blood transfusion.
History of peptic ulcer.
known hypersensitivity to iron preparations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amaal khalil, master
Phone
02201154883113
Email
amaal.moussa@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
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