Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations

August 3, 2016 updated by: Mohammed Khairy Ali, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 27 mg elemental iron group
received 27 mg elemental iron once daily starting at 12 weeks until 36 weeks
Drug: 27 mg elemental iron
Active Comparator: 54 mg elemental iron group
received 54 mg elemental iron once daily starting at 12 weeks until 36 weeks
Drug: 54 mg elemental iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin level
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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