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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

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE December 20, 2017
Last Update Posted Date December 20, 2017
Actual Study Start Date  ICMJE December 31, 2015
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
Hemoglobin level [ Time Frame: At 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women
Official Title  ICMJE Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia of Pregnancy
Intervention  ICMJE
  • Drug: Iron bisglycinate Oral Tablet
  • Drug: Ferrous Fumarate Oral Tablet
Study Arms  ICMJE
  • Experimental: Group A
    Iron bisglycinate (27mg of elemental iron)
    Intervention: Drug: Iron bisglycinate Oral Tablet
  • Active Comparator: Group B
    Ferrous fumarate (115mg of elemental iron)
    Intervention: Drug: Ferrous Fumarate Oral Tablet
Publications * Kamdi SP, Palkar PJ. Efficacy and safety of ferrous asparto glycinate in the management of iron deficiency anaemia in pregnant women. J Obstet Gynaecol. 2015 Jan;35(1):4-8. doi: 10.3109/01443615.2014.930098. Epub 2014 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2017)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03378791
Other Study ID Numbers  ICMJE MS/15.10.05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hatem AbuHashim, Mansoura University
Study Sponsor  ICMJE Hatem AbuHashim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hatem Abu Hashim, MD. MRCOG. PhD Faculty of Medicine, Mansoura University
Principal Investigator: Ahmed Ismail, MBBCh Mansoura University Hospitals
PRS Account Mansoura University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP