- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03484845
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: amaal khalil, master
- Phone Number: 02201154883113
- Email: amaal.moussa@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oral lactoferrin
women who take oral lactoferrin sachets 100 mg twice daily for one month.
|
Other Names:
|
Active Comparator: Oral ferrous fumarate
women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.
|
Other Names:
|
Active Comparator: Combined lactoferrin & ferrous fumarate
women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase in blood hemoglobin.
Time Frame: one month
|
mean difference in hemoglobin level between pre treatment and post treatment.
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- u1111-1210-1436
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Deficiency Anemia of Pregnancy
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The University of Texas Medical Branch, GalvestonTerminatedPregnancy Related | Iron Deficiency Anemia of PregnancyUnited States
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Thomas Jefferson UniversityAuerbach Hematology and OncologyRecruitingPregnancy Related | Anemia, Iron Deficiency | Anemia of PregnancyUnited States
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University of Lagos, NigeriaAminu Kano Teaching HospitalCompletedIron Deficiency Anemia of PregnancyNigeria
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Cairo UniversityCompleted
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Boston University Charles River CampusLata Medical Research FoundationUnknownAnemia | Anemia, Iron Deficiency | Anemia of PregnancyIndia
-
University of ArizonaAMAG Pharmaceuticals, Inc.CompletedIron Deficiency Anemia of PregnancyUnited States
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UConn HealthCompleted
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Swiss Federal Institute of TechnologyMahidol UniversityUnknownIron Deficiency Anemia of PregnancyThailand
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Ain Shams UniversityCompletedIron Deficiency Anemia of PregnancyEgypt
-
Pharmacosmos A/SCompletedIron Deficiency Anemia of PregnancyDenmark
Clinical Trials on Lactoferrin and ferrous fumarate
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Swiss Federal Institute of TechnologyUniversity of Zurich; University Children's Hospital, Zurich; Jomo Kenyatta University...CompletedAnemia, Iron-deficiencyKenya
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Swiss Federal Institute of TechnologyCompletedIron-deficiencySwitzerland
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Swiss Federal Institute of TechnologyBurgerstein VitamineCompletedIron-deficiencySwitzerland
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dora pereiraUniversity of Oxford; University of Cambridge; Bangor UniversityCompleted
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Prince of Songkla UniversityThe Thai Society of HematologyCompletedIron Deficiency AnemiaThailand
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Thomas WalczykUnknownEffect of Iron Status on Occurrence of NTBISingapore
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Isabelle Herter-AeberliBurgerstein VitamineCompletedIron-deficiencySwitzerland
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Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
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Isabelle Herter-AeberliBurgerstein VitamineCompletedLow Iron StoresSwitzerland
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yasmin gamal el gendyCompletedIron Deficiency AnemiaEgypt