Efficacy of Iron Bisglycinate in Treatment of Iron Defici... | NCT03378791

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

NCT03378791

Sponsor

Hatem AbuHashim

Status

Completed

Last Update Posted

Dec 20, 2017Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Iron Deficiency Anemia of Pregnancy

Interventions

Iron bisglycinate Oral Tablet
Ferrous Fumarate Oral Tablet

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2015Actual

Primary Completion Date

Oct 31, 2017Actual

Completion Date

Oct 31, 2017Actual

First Submitted Date

Dec 14, 2017

First Submission Date that Met QC Criteria

Dec 14, 2017

First Posted Date

Dec 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2017

Last Update Posted Date

Dec 20, 2017Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Iron bisglycinate (27mg of elemental iron)	Drug: Iron bisglycinate Oral Tablet
Group B	Active Comparator	Ferrous fumarate (115mg of elemental iron)	Drug: Ferrous Fumarate Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron bisglycinate Oral Tablet	Drug		Group A
Ferrous Fumarate Oral Tablet

Measure	Description	Time Frame
Hemoglobin level		At 4 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hatem Abu Hashim, MD. MRCOG. PhD	Faculty of Medicine, Mansoura University	Study Chair
Ahmed Ismail, MBBCh	Mansoura University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University Hospitals		Al Mansurah	Dakahlia Governorate		Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24959663	Background	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.