Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations
Primary Purpose
Anemia
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
27 mg elemental iron
54 mg elemental iron
Sponsored by
About this trial
This is an interventional prevention trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- twin gestations
- ±12 weeks)
- normal hemoglobin level (Hb ≥ 120 g/L).
- women were living in nearby area to make up follow up quit possible
- willing to participate in our study
Exclusion Criteria:
- a recent blood transfusion
- threatened miscarriage
- pathological blood loss
- vegetarian diet
- intolerant to oral iron form
- history of haematologic disorder
- chronic diseases
- unwillingness to co-operate.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
27 mg elemental iron group
54 mg elemental iron group
Arm Description
received 27 mg elemental iron once daily starting at 12 weeks until 36 weeks
received 54 mg elemental iron once daily starting at 12 weeks until 36 weeks
Outcomes
Primary Outcome Measures
Hemoglobin level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02858505
Brief Title
Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. During pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass.
Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman needs about 1000 mg of iron during pregnancy.
Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further Iron deficiency anemia.
Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting.
Iron amino acid chelates have been emerged to be used as agents for prevention and treatment of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects.
Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. The iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
27 mg elemental iron group
Arm Type
Active Comparator
Arm Description
received 27 mg elemental iron once daily starting at 12 weeks until 36 weeks
Arm Title
54 mg elemental iron group
Arm Type
Active Comparator
Arm Description
received 54 mg elemental iron once daily starting at 12 weeks until 36 weeks
Intervention Type
Drug
Intervention Name(s)
27 mg elemental iron
Intervention Type
Drug
Intervention Name(s)
54 mg elemental iron
Primary Outcome Measure Information:
Title
Hemoglobin level
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
twin gestations
±12 weeks)
normal hemoglobin level (Hb ≥ 120 g/L).
women were living in nearby area to make up follow up quit possible
willing to participate in our study
Exclusion Criteria:
a recent blood transfusion
threatened miscarriage
pathological blood loss
vegetarian diet
intolerant to oral iron form
history of haematologic disorder
chronic diseases
unwillingness to co-operate.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations
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