The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
NCT ID: NCT04101461
Last Updated: 2022-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2019-10-01
2022-04-01
Brief Summary
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The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.
Obesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.
Many researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group I: 27 mg elemental iron
will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks
Iron
PharaFerro27; Devart Lab Company, Egypt
Complete blood count
to assess the anemia
Serum ferritin
to assess the anemia
Serum hepcidin
to assess the iron abosrption
Serum Iron
to assess the anemia
Serum total iron binding capacity
to assess the anemia
Group II: 54 mg elemental iron
will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks
Iron
PharaFerro27; Devart Lab Company, Egypt
Complete blood count
to assess the anemia
Serum ferritin
to assess the anemia
Serum hepcidin
to assess the iron abosrption
Serum Iron
to assess the anemia
Serum total iron binding capacity
to assess the anemia
Interventions
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Iron
PharaFerro27; Devart Lab Company, Egypt
Complete blood count
to assess the anemia
Serum ferritin
to assess the anemia
Serum hepcidin
to assess the iron abosrption
Serum Iron
to assess the anemia
Serum total iron binding capacity
to assess the anemia
Eligibility Criteria
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Inclusion Criteria
2. BMI (30- 40 kg/m2).
3. Normal hemoglobin level (\>11 g/dL).
4. Normal hematocrit (Hct 31-41%).
5. Normal ferritin level (6-130 ng/mL).
6. Women willingness to participate in the study.
7. Women living in the nearby area to make follow-up visits possible.
Exclusion Criteria
2. Women received a recent blood transfusion.
3. Women with threatened miscarriage.
4. Women are known to have pathological blood loss.
5. Intolerant to oral iron form.
6. History of the hematologic disorder.
7. Women used iron in the past 3 months.
8. Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease……).
20 Years
35 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohammed Khairy Ali
Lecturer
Locations
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Woman's Health Hospital - Assiut university
Asyut, , Egypt
Countries
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Other Identifiers
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IDA-Obese
Identifier Type: -
Identifier Source: org_study_id
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