The Effect of Iron Deficiency Anemia During Pregnancy

NCT02590224 | Completed Phase 4

• 1 other identifier: IDA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations. Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication. Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• the rate of increase of Hemoglobin level

  difference in hemoglobin concentrations before and after treatment

  8 weeks

Study Arms (2)

Ferrous bis-glycinate group

ACTIVE COMPARATOR

The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks.

Drug: Ferrous bis-glycinate

Ferrous glycine sulphate group

ACTIVE COMPARATOR

The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks.

Drug: Ferrous glycine sulphate

Interventions

Ferrous bis-glycinate DRUG

Ferrous bis-glycinate group

Ferrous glycine sulphate DRUG

Ferrous glycine sulphate group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy.
• Gestational age 14-18 weeks.
• Mild to moderate anemia
• No associated medical or obstetric complications.
• Women not already receiving iron therapy.
• Women accepted to participate in the study.

You may not qualify if:

• Multiple pregnancy
• Severe anemia
• Iron hypersensitivity.
• Liver diseases.
• Women refuse to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferroglycine sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

EG (1)