Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590831
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Lactoferrin Alone Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lactoferrin Alone Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia During the 3rd Trimester of Pregnancy Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iron deficiency ID and iron deficiency anemia IDA are the most common iron disorders throughout the world
ID and IDA particularly caused by increased iron requirements during pregnancy represent a high risk for preterm delivery fetal growth retardation low birth weight and inferior neonatal health These pregnancy complications are thought to occur because of an increased iron requirement related to enhanced blood volume and development of the fetoplacental unit
ID and IDA particularly caused by increased iron requirements during pregnancy represent a high risk for preterm delivery fetal growth retardation low birth weight and inferior neonatal health These pregnancy complications are thought to occur because of an increased iron requirement related to enhanced blood volume and development of the fetoplacental unit
Detailed Description:
The World Health Organization WHO defines anemia in pregnancy as a hemoglobin Hb concentration of 11 gdl Centers for disease control prevention determine a cut of -off point 105 gdl during 2nd trimester for diagnosis of IDA
Iron deficiency anemia IDA is the most common type of anemia in pregnancy The iron content of the body is normally kept constant by regulating the amount absorbed to balance the amount lost
The WHO estimates that 46 of pregnant women in African region 38 in Eastern Mediterranean region 25 in European region and 24 in the region of the Americas are anemic mainly because of iron deficiency Anemia is a common medical disorder affecting a lot of women in pregnancy in the developing countries
Management of anemia remain an important issue in prenatal medicine Correct diagnosis and treatment lead to effective management of fetal and maternal risk and improved prenatal outcome Diet alone cant supply the 30-40 mg iron that is required for absorption of 4-6mg iron per day needed during the later stage of pregnancy so iron supplementation is strongly recommended for all females in developing countries
Traditional therapeutic options of iron deficiency anemia during pregnancy were administration of oral iron shows lack of compliance and side effects and often limited intestinal absorption and bioavailability The most used treatment for ID and IDA currently consists of oral administration of iron as ferrous sulphate However ferrous sulphate administration often fails to exert any significant effects on these pregnancy-associated pathologies and frequently causes several adverse effects
This is likely due to the poor bioavailability of inorganic iron requiring the administration of large quantity of ferrous sulphate Lactoferrin is a multifunctional protein of the transferrin family Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids such as milk saliva tears and nasal secretions Lactoferrin is also present in secondary granules of Polymorpho nuclear leucocyte and is secreted by some acinar cells Lactoferrin can be purified from milk or produced recombinantly
Lactoferrin previously lactotransferrinis a glycoprotein that belongs to transferrin family which includes protiens that may bind transferrinLactoferrin levels in cow milk human milk colostrum are roughly seven times higher than lactoferrin levels in milk prouduced later
Iron deficiency anemia IDA is the most common type of anemia in pregnancy The iron content of the body is normally kept constant by regulating the amount absorbed to balance the amount lost
The WHO estimates that 46 of pregnant women in African region 38 in Eastern Mediterranean region 25 in European region and 24 in the region of the Americas are anemic mainly because of iron deficiency Anemia is a common medical disorder affecting a lot of women in pregnancy in the developing countries
Management of anemia remain an important issue in prenatal medicine Correct diagnosis and treatment lead to effective management of fetal and maternal risk and improved prenatal outcome Diet alone cant supply the 30-40 mg iron that is required for absorption of 4-6mg iron per day needed during the later stage of pregnancy so iron supplementation is strongly recommended for all females in developing countries
Traditional therapeutic options of iron deficiency anemia during pregnancy were administration of oral iron shows lack of compliance and side effects and often limited intestinal absorption and bioavailability The most used treatment for ID and IDA currently consists of oral administration of iron as ferrous sulphate However ferrous sulphate administration often fails to exert any significant effects on these pregnancy-associated pathologies and frequently causes several adverse effects
This is likely due to the poor bioavailability of inorganic iron requiring the administration of large quantity of ferrous sulphate Lactoferrin is a multifunctional protein of the transferrin family Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids such as milk saliva tears and nasal secretions Lactoferrin is also present in secondary granules of Polymorpho nuclear leucocyte and is secreted by some acinar cells Lactoferrin can be purified from milk or produced recombinantly
Lactoferrin previously lactotransferrinis a glycoprotein that belongs to transferrin family which includes protiens that may bind transferrinLactoferrin levels in cow milk human milk colostrum are roughly seven times higher than lactoferrin levels in milk prouduced later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None