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Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women

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ClinicalTrials.gov Identifier: NCT03378791
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hatem AbuHashim, Mansoura University

Study Description
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Brief Summary:

Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11 g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the bioavailability of iron preparation, however it also increases the frequency of gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by many foods and / or chelating drugs in the gastrointestinal tract which interfere with its absorption leading to variability in the hemoglobin correction during the treatment.

Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron with two molecules of the amino acid glycine by a covalent bound in a process called chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves iron absorption, storage and increase hemoglobin level better than the conventionally used iron salts.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia of Pregnancy Drug: Iron bisglycinate Oral Tablet Drug: Ferrous Fumarate Oral Tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women
Actual Study Start Date : December 31, 2015
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Iron bisglycinate (27mg of elemental iron)
 Drug: Iron bisglycinate Oral Tablet
Active Comparator: Group B
Ferrous fumarate (115mg of elemental iron)
 Drug: Ferrous Fumarate Oral Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin level [ Time Frame: At 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women aged 20 to 40 years,
  • 14-27 gestational weeks calculated from the first day of their last menstrual period and confirmed by ultrasound
  • Singleton fetus
  • hemoglobin level from 7-9.9 g/dL.

Exclusion Criteria:

  • All women with high risk pregnancy e.g. hypertension, diabetes
  • multiple pregnancy
  • women with severe anemia (Hb >7 g/dl)
  • anemia due to other causes than iron deficiency as chronic blood loss, hemolytic anemia or thalassemia.
  • women with hepatic, renal or cardiovascular abnormality; women with peptic ulcer, esophagitis, gastritis or hiatus hernia
  • family history of thalassemia, sickle cell anemia, or malabsorption syndrome
  • hypersensitivity to iron preparations or current use of iron supplementation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378791


Locations
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Egypt
Mansoura University Hospitals
Mansourah, Dakahlia Governorate, Egypt
Sponsors and Collaborators
Hatem AbuHashim
Investigators
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Study Chair: Hatem Abu Hashim, MD. MRCOG. PhD Faculty of Medicine, Mansoura University
Principal Investigator: Ahmed Ismail, MBBCh Mansoura University Hospital
More Information
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Publications:

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Responsible Party: Hatem AbuHashim, Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT03378791    
Other Study ID Numbers: MS/15.10.05
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Iron Deficiencies
Deficiency Diseases
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
 Anemia, Hypochromic
Malnutrition
Nutrition Disorders
Ferrous fumarate
Trace Elements
Micronutrients
Physiological Effects of Drugs