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Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy

Primary Purpose

Treatment of Iron Deficiency Anemia in Pregnancy

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Theragran Hematinic
low molecular weight iron dextran
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Iron Deficiency Anemia in Pregnancy focused on measuring Iron deficiency anemia, Pregnancy, Iron therapy

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Maternal age 20-35 years old.
  • Singleton pregnancy between 16 - 24 weeks.
  • Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study.

Exclusion Criteria:

  • Extremes of reproductive age (less than 20 years old or more than 35 years old).
  • Patients with multiple pregnancies.
  • Anemia not linked to iron deficiency.
  • Allergy to iron derivatives.
  • Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer.
  • Those who had received parenteral iron treatment earlier within 3 months before the start of the study.
  • Any obstetric complicating factors like pregnancy induced hypertension.
  • Patients with history of chronic blood loss.

Sites / Locations

  • Maternity Hospital, Faculty of Madicine, AinShams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Theragran Hematinic, oral iron, 120 mg elemental iron/

low molecular weight iron dextran, total dose infusion

Arm Description

pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar.

Pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R pharmacosmos Denmark (Inspire Pharma Egypt). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status. Total iron dose (mg) = weight (kg) X Hemoglobin deficit {target Hemoglobin (g/l)- Actual Hemoglobin (g/l)} X 0.24 + 500 mg.

Outcomes

Primary Outcome Measures

The proportion of patients who have been successfully treated
The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of > 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy).

Secondary Outcome Measures

Number of participants with adverse effects

Full Information

First Posted
March 12, 2014
Last Updated
March 17, 2015
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02086838
Brief Title
Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Official Title
Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.
Detailed Description
Patients will be allocated to two groups of 106 each and to insure that everyone has the chance of participation, randomization will be guided by table of random numbers All women recruited in the study will be given 100 mg mebendazole tablets twice daily for 3 days for de-worming and 500 micro gram folic acid daily till the end of the study The required dose will be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status Total iron dose (mg) = weight (kg) X hemoglobin deficit {target hemoglobin (g/l)- Actual hemoglobin (g/l)} X 0.24 + 500 mg The total iron dose needed will be calculated by formula rounded to nearest multiple of 100 Group I includes pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® Smith-Kline Beecham, Egypt an affiliated co. to Glaxo Smith-Kline, according to the WHO guidelines for IDA control Group II includes pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R Pharmacosmos Denmark (Inspire Pharma Egypt) Inclusion criteria Maternal age 20-35 years old. Singleton pregnancy between 16 - 24 weeks Iron deficiency anemia with average hemoglobin ranging from 7-9 g/dL at the onset of the study Exclusion criteris Extremes of reproductive age (less than 20 years old or more than 35 years old). Patients with multiple pregnancies. Anemia not linked to iron deficiency. Allergy to iron derivatives. Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer. Those who had received parenteral iron treatment earlier within 3 months before the start of the study. Any obstetric complicating factors like pregnancy induced hypertension (PIH). Patients with history of chronic blood loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Iron Deficiency Anemia in Pregnancy
Keywords
Iron deficiency anemia, Pregnancy, Iron therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theragran Hematinic, oral iron, 120 mg elemental iron/
Arm Type
Active Comparator
Arm Description
pregnant women taking 60 mg elemental iron twice per day (120 mg/day) using iron tablets (Theragran Hematinic)® SmithKline Beecham, Egypt an affiliated co. to GlaxoSmithKline. Adherence to the treatment will be monitored by asking the women to bring back the empty packs and mark the consumption of tablets on calendar.
Arm Title
low molecular weight iron dextran, total dose infusion
Arm Type
Active Comparator
Arm Description
Pregnant women taking elemental iron in the form of low molecular weight dextran complex intravenously as a total dose infusion (T.D.I) using iron dextran ampules (Cosmofer)R pharmacosmos Denmark (Inspire Pharma Egypt). Patients selected for parental iron will be admitted as day cases in the hospital in a single visit. The required dose has to be individually adapted according to the total iron deficit which is dependent on the patient's body weight and hemoglobin status. Total iron dose (mg) = weight (kg) X Hemoglobin deficit {target Hemoglobin (g/l)- Actual Hemoglobin (g/l)} X 0.24 + 500 mg.
Intervention Type
Drug
Intervention Name(s)
Theragran Hematinic
Intervention Type
Drug
Intervention Name(s)
low molecular weight iron dextran
Other Intervention Name(s)
Cosmofer
Primary Outcome Measure Information:
Title
The proportion of patients who have been successfully treated
Description
The proportion of patients who have been successfully treated as evidenced by a hemoglobin concentration of > 10.5 g% after 8 weeks from completing treatment (oral or total iron dose infusion therapy).
Time Frame
up to 8 weeks from comleting treatment
Secondary Outcome Measure Information:
Title
Number of participants with adverse effects
Time Frame
up to 8 weeks after completing treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Maternal age 20-35 years old. Singleton pregnancy between 16 - 24 weeks. Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study. Exclusion Criteria: Extremes of reproductive age (less than 20 years old or more than 35 years old). Patients with multiple pregnancies. Anemia not linked to iron deficiency. Allergy to iron derivatives. Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer. Those who had received parenteral iron treatment earlier within 3 months before the start of the study. Any obstetric complicating factors like pregnancy induced hypertension. Patients with history of chronic blood loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S. Sweed, MD
Organizational Affiliation
AinShams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hazem M. Sammour, Professor
Organizational Affiliation
AinShams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdel-Latif G. El-Kholy, Ass. Prof.
Organizational Affiliation
AinShams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eman M. El-Garhi, M.B.B.Ch.
Organizational Affiliation
El Galaa Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity Hospital, Faculty of Madicine, AinShams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy

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