Clinical trial NCT03378791: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia of Pregnancy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hemoglobin level
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Hospitals
state: Dakahlia Governorate
Study officials:
affiliation: Faculty of Medicine, Mansoura University
name: Hatem Abu Hashim, MD. MRCOG. PhD
role: STUDY_CHAIR
affiliation: Mansoura University Hospital
name: Ahmed Ismail, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.