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

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

Tracking Information

• First Submitted Date: December 14, 2017
• First Posted Date: December 20, 2017
• Last Update Posted Date: December 20, 2017
• Actual Study Start Date: December 31, 2015
• Actual Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 14, 2017): Hemoglobin level [ Time Frame: At 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Iron Deficiency Anemia of Pregnancy

Intervention

• Drug: Iron bisglycinate Oral Tablet
• Drug: Ferrous Fumarate Oral Tablet

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2017): 120
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 31, 2017
• Actual Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03378791
• Other Study ID Numbers: MS/15.10.05
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hatem AbuHashim, Mansoura University
• Original Responsible Party: Same as current
• Current Study Sponsor: Hatem AbuHashim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Hatem Abu Hashim, MD. MRCOG. PhD; Faculty of Medicine, Mansoura University
• Principal Investigator: Ahmed Ismail, MBBCh; Mansoura University Hospital

• PRS Account: Mansoura University
• Verification Date: December 2017