Iron Deficiency Anemia
Conditions
Brief summary
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.
Detailed description
The investigator will divide the participants into two groups e.g. group (A) and group (B) according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with health education in case of group (A) and without health education in case of group (B). Then the investigator asked patient to sign the document of her investigations result to receive iron supplementation. * After that, the investigator observes hemoglobin's Level, when it less than \>11g/dl, the patient will be the group (A) who will receive oral iron supplementation and health education. * Group (B) who will receive Total Dose Infusion (TDI) without health education.
Interventions
COMBINATION_PRODUCTOral lactoferrin
Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.
COMBINATION_PRODUCTTDI of LMW iron dextran
Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
Sponsors
Woman's Health University Hospital, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Group A will receive oral lactoferrin & group B will receive Total dose infusion
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant Women aged \>18 years 2. Hemoglobin\<10g/dl 3. Gestational age between 14-28 weeks 4. Singleton pregnancy 5. Willingness to participate and signing the informed consent form
Exclusion criteria
1. Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia), 2. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis). 3. Decompensated liver cirrhosis and active hepatitis (ALAT\>3 times upper limit of normal). 4. Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP). 5. Rheumatoid arthritis with symptoms or signs of active inflammation. 6. Multiple allergies. 7. Known hypersensitivity to parental iron or any recipients in the investigational drug products. 8. Erythropoietin treatment within 8 weeks prior to the screening visit. 9. Other iron treatment within 8 weeks prior to the screening visit. 10. Planned elective surgery during the study. 11. Participation in any other clinical within 3 months prior to the screening. 12. Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in Hb concentration | 4- 8 weeks | measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measure the change in serum iron, serum ferritin | 4-8 weeks | measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education & TDI from hospital routine care. |
Countries
Egypt
Outcome results
None listed