Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia
Conditions
Keywords
iron deficiency anemia during pregnancy, ferrous gluconate, lactoferrin
Brief summary
Study Procedures: All patients will undergo the following: Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations. 1. History taking: * Personal history: name, age, occupation and address. * Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration. * Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin. 2. Medical examination: * General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill) * Abdominal examination to assess fundal height. 3. Investigations to perform will include: Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules. Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation. Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.
Detailed description
This study included two groups: Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily. hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
Interventions
iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day
DRUGferrous gluconate with lactoferrin
Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Total 40 females from 14 to 35 weeks of pregnancy with Hemoglobin level between 8.5 to 10.5 gm/dl, recruited from the obstetric inpatient/outpatient clinic at Ain Shams University, Maternity hospital. This study included two groups: Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily. Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily. hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* The study will include women with the following inclusion and
Exclusion criteria
Inclusion criteria: 1. Pregnant women with single fetus 2. Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl) 3. Gestational age (14 - 35 weeks) 4. Serum ferritin level <24 ng/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Hemoglobin (Hb) level | 4 weeks | hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl) |
| serum ferritin | 4 weeks | serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gastrointestinal side effects | 4 weeks | (nausea , vomiting , constipation ) will be assessed before and after treatment |
Countries
Egypt
Outcome results
None listed