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The Use of Iron Therapy for Patients With Anemia After Surgery (VITAPOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975272
Recruitment Status : Unknown
Verified October 2013 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2013
Last Update Posted : November 4, 2013
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after gynaecologic surgery.

Condition or disease Intervention/treatment Phase
Postoperative Anaemia Drug: Ferinject Drug: Ferrous fumarate Drug: Placebo for ferrous fumarate Drug: Placebo for ferinject Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Value of Iron Treatment for Postoperative Patients With Anemia: a Randomized Double Blind Controlled Trial
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Ferinject
Once an infusion of Ferinject 1000 mg, 1 day after surgery
Drug: Ferinject
Other Names:
  • intravenous iron
  • ferric carboxymaltose

Drug: Placebo for ferrous fumarate
Other Name: Placebo tablets

Active Comparator: Ferrous fumarate
2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
Drug: Ferrous fumarate
Other Names:
  • Oral iron
  • Iron (II) fumarate

Drug: Placebo for ferinject
Other Name: NaCl

Placebo Comparator: Placebo infusion and tablets
Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery
Drug: Placebo for ferrous fumarate
Other Name: Placebo tablets

Drug: Placebo for ferinject
Other Name: NaCl




Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: 3 weeks postoperative ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1,3 and 6 weeks postoperative ]
    Quality of life will be determined by using the next questionnaires: European Health Related Quality of Life (euro HRQol) and Multidimensional Fatigue Inventory (MFI)

  2. Side effects of medication [ Time Frame: 1,3 and 6 weeks postoperative ]
    In the questionnaire one has to fill out if there are any side effects like Nausea; Stomach ache; constipation; Diarrhea; Skin rash; Headache; Dizziness; Other....

  3. Predictive value of other parameters C reactive protein (CRP) ,transferrin, ferritin, hepcidin [ Time Frame: 3 and 6 weeks postoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gynecological surgery
  • Hb 5-7 mmol/L

Exclusion Criteria:

  • Pregnancy
  • Oncological operations
  • Infections (PID)
  • Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
  • Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
  • Small vulvar / vaginal operations such as (cysts, labia correction)
  • Endometrial ablation
  • Legal incapacity
  • The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
  • Hematologic disorders
  • Erythropoiesis-stimulating agents < 3months ago
  • Myelosuppressive therapy in history
  • Hepatitis
  • HIV
  • Alcohol abuses
  • Not understanding Dutch
  • Allergic reaction to iron therapy in past

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): NCT01975272


Contacts
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Contact: Celine CMJG Lardenoije, Drs. 00316-17028468 c.lardenoije@gmail.com
Contact: Roy RFPM Kruitwagen, Prof. Dr. 0031-433874764 r.kruitwagen@mumc.nl

Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Principal Investigator: Roy RFPM Kruitwagen, Prof. Dr.         
Orbis Medical Centre
Sittard, Limburg, Netherlands, 6162 BG
Principal Investigator: Celine CMJG Lardenoije, Drs.         
Sponsors and Collaborators
Maastricht University Medical Center
Vifor Pharma

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01975272    
Other Study ID Numbers: METC 12-2-018
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2013
Keywords provided by Maastricht University Medical Center:
postoperative
anemia
gynaecologic
surgery
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron
Ferrous fumarate
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics