Iron Deficiency Anemia
Conditions
Brief summary
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
Detailed description
Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).
Interventions
DRUGAmino Acid chelated iron tab 15 mg
Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product. Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption. Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption. Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
DRUGFerrous Fumarate tab 350 mg( 115 mg elemental iron)
75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb\<9g/dl) this dose can be doubled as recommended by the company of the product. Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption. Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption. Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound * Hemoglobin level 8-10.5 g/dL * Serum ferritin\<15µg/L
Exclusion criteria
* The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect…). * Multiple gestations * The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease * Patients with known gastritis * History of mal-absorption syndrome * Those with known hypersensitivity to iron preparations * Those under current iron supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobine (Hb) Rise | after 12 weeks of treatment. | follow up CBC after 12 weeks of treatment given |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobine (Hb) Rise | after 4,8 weeks of treatment. | Follow up CBC after 4,8 weeks of treatment given |
| Adverse effects of the medication given | 3months | constipation, nausea, allergy. |
Countries
Egypt
Contacts
Primary ContactAhmed Elshahawy, MD
Outcome results
None listed