Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631612
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia a Hospital Based Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to learn if giving iron supplementation every other day is as effective as giving it daily in children with Iron Deficiency Anemia
The main questions it aims to answer are
1 Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose
2 Which group will suffer less side effects from Iron Supplementation
Participants will be divided into two groups
Group A will receive oral Iron supplementation daily for 2 months Group B will receive oral Iron supplementation every other day for 2 months Participants will be monitored using weekly phone calls to insure compliance and report side effects
Both groups will be given Albendazole 400 mg once at the beginning of the study to be repeated in 1 week
The main questions it aims to answer are
1 Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose
2 Which group will suffer less side effects from Iron Supplementation
Participants will be divided into two groups
Group A will receive oral Iron supplementation daily for 2 months Group B will receive oral Iron supplementation every other day for 2 months Participants will be monitored using weekly phone calls to insure compliance and report side effects
Both groups will be given Albendazole 400 mg once at the beginning of the study to be repeated in 1 week
Detailed Description:
Children will be recruited from the pediatrics general clinic in Al Demerdash Hospital
After checking fro inclusion and exclusion criteria and signing the informed consent form the following will be carried out
1-History taking Caregivers will be asked about
1 Sociodemographic data using a self-structured questionnaire
Age of the child
Gender of the child
Order of birth
Consanguinity
Mode of delivery either vaginal delivery or by c-section
Age of the mother and father
Level of education or the mother and father
Address of the family
2 Questions about risk factors for iron deficiency anemia to exclude other causes of anemia
Prematurity low birth weight
Duration of exclusive breast feeding
Consumption of cow milk before 1 year of ageexcessive consumption of cow milk
Mothers iron status during pregnancy
family history for hemolytic anemias or regular blood transfusions
history of blood transfusions or hemolysis pallor jaundice dark urineanemia
History of chronic illness Cardiac hepatic or renal patients
History of chronic blood loss
3 Questions about symptoms of iron deficiency anemia
Headache lack of concentrationfatigue palpitations irritabilityfainting wanting to eat odd substances such as dirt or ice also called picaetc
2-Examination
General examination
1 Anthropometric measures weightheightBMI
2 Look for signs of anemia Pallor brittle hair and nailsangular stomatitisglossitis Koilonychia or spooning of nails tachycardia hyperdynamic circulation
3 Abdominal examination look for tenderness masses or hepatosplenomegaly 3-Investigations a blood sample of about 5 ml will be drawn twice once at presentation and again after 8 weeks Complete Blood Picture CBC Iron profile serum iron TIBC Participants will be divided into two groups
Both groups will receive
1 Health education regarding IDA including
Prenatal and postnatal nutrition the definition of anemia diagnosis of anemia factors causing anemia sources of heme and non-heme iron foods and nutrients that interfere with and promote iron absorption and the impact of anemia on toddlers Also food sources high in nutrients and processing high iron content of complementary breastfeeding
2 Treatment for parasitic infections deworming Albendazole 400 mg once
Then
Group 1 will receive daily dose of 3 mgkg ferrous fumarate before bed Group 2 will receive a dose of 6mgkg ferrous fumarate before bed every other day with a maximum dose of 180 mg day
Participants will be dedicated to the study for 8 weeks During this time they will be monitored using weekly phone calls to
1 Reinforce the health education message
2 make sure they are compliant to their treatment
3 monitor if any new symptoms or side effects appear
Outcomes
Participants will be followed for 8 weeks Check in after 8 weeks to repeat hemoglobin levels and serum Iron and TIBC
After checking fro inclusion and exclusion criteria and signing the informed consent form the following will be carried out
1-History taking Caregivers will be asked about
1 Sociodemographic data using a self-structured questionnaire
Age of the child
Gender of the child
Order of birth
Consanguinity
Mode of delivery either vaginal delivery or by c-section
Age of the mother and father
Level of education or the mother and father
Address of the family
2 Questions about risk factors for iron deficiency anemia to exclude other causes of anemia
Prematurity low birth weight
Duration of exclusive breast feeding
Consumption of cow milk before 1 year of ageexcessive consumption of cow milk
Mothers iron status during pregnancy
family history for hemolytic anemias or regular blood transfusions
history of blood transfusions or hemolysis pallor jaundice dark urineanemia
History of chronic illness Cardiac hepatic or renal patients
History of chronic blood loss
3 Questions about symptoms of iron deficiency anemia
Headache lack of concentrationfatigue palpitations irritabilityfainting wanting to eat odd substances such as dirt or ice also called picaetc
2-Examination
General examination
1 Anthropometric measures weightheightBMI
2 Look for signs of anemia Pallor brittle hair and nailsangular stomatitisglossitis Koilonychia or spooning of nails tachycardia hyperdynamic circulation
3 Abdominal examination look for tenderness masses or hepatosplenomegaly 3-Investigations a blood sample of about 5 ml will be drawn twice once at presentation and again after 8 weeks Complete Blood Picture CBC Iron profile serum iron TIBC Participants will be divided into two groups
Both groups will receive
1 Health education regarding IDA including
Prenatal and postnatal nutrition the definition of anemia diagnosis of anemia factors causing anemia sources of heme and non-heme iron foods and nutrients that interfere with and promote iron absorption and the impact of anemia on toddlers Also food sources high in nutrients and processing high iron content of complementary breastfeeding
2 Treatment for parasitic infections deworming Albendazole 400 mg once
Then
Group 1 will receive daily dose of 3 mgkg ferrous fumarate before bed Group 2 will receive a dose of 6mgkg ferrous fumarate before bed every other day with a maximum dose of 180 mg day
Participants will be dedicated to the study for 8 weeks During this time they will be monitored using weekly phone calls to
1 Reinforce the health education message
2 make sure they are compliant to their treatment
3 monitor if any new symptoms or side effects appear
Outcomes
Participants will be followed for 8 weeks Check in after 8 weeks to repeat hemoglobin levels and serum Iron and TIBC
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