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Trial record 32 of 36 for:    pharmacosmos

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

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ClinicalTrials.gov Identifier: NCT02086838
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Treatment of Iron Deficiency Anemia in Pregnancy Drug: Theragran Hematinic Drug: low molecular weight iron dextran Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Theragran Hematinic, oral iron, 120 mg elemental iron/
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.
Drug: Theragran Hematinic
Active Comparator: low molecular weight iron dextran, total dose infusion
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.
Drug: low molecular weight iron dextran
Other Name: Cosmofer




Primary Outcome Measures :
  1. The proportion of patients who have been successfully treated [ Time Frame: up to 8 weeks from comleting treatment ]
    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 :
  1. Number of participants with adverse effects [ Time Frame: up to 8 weeks after completing treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086838


Locations
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Egypt
Maternity Hospital, Faculty of Madicine, AinShams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed S. Sweed, MD AinShams University
Study Director: Hazem M. Sammour, Professor AinShams University
Principal Investigator: Abdel-Latif G. El-Kholy, Ass. Prof. AinShams University
Principal Investigator: Eman M. El-Garhi, M.B.B.Ch. El Galaa Teaching Hospital

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Responsible Party: Mohamed S Sweed, MD, Lecturer of Obstetrics and Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT02086838     History of Changes
Other Study ID Numbers: 9020058
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
Iron deficiency anemia
Pregnancy
Iron therapy

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Dextrans
Iron-Dextran Complex
Hematinics
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Plasma Substitutes
Blood Substitutes