Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty (ISAPA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Juan Carlos Montano Pedroso, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01857011
First received: May 8, 2013
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine whether intravenous or oral iron are effective in the treatment of postoperative anemia and iron deficiency in patients submitted in postbariatric abdominoplasty.


Condition Intervention Phase
Anemia, Iron-Deficiency
Weight Loss
Drug: Intravenous Iron sucrose
Drug: Oral Iron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Hemoglobin level [ Time Frame: 8 postoperative weeks ] [ Designated as safety issue: No ]
    Hemoglobin level measured at 8 postoperative weeks


Secondary Outcome Measures:
  • Ferritin levels [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ] [ Designated as safety issue: No ]
  • FACIT [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ] [ Designated as safety issue: No ]
    The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.

  • SF36 [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ] [ Designated as safety issue: No ]
    Quality of Life Questionnaire

  • Transferrin saturation [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ] [ Designated as safety issue: No ]
  • Hemoglobin levels [ Time Frame: preoperative (one day before surgery) and 1, 4 postoperative weeks ]

Estimated Enrollment: 56
Study Start Date: April 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Iron
Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
Drug: Intravenous Iron sucrose
Active Comparator: Oral Iron
Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
Drug: Oral Iron

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • 18 a 55 years
  • Prior open or laparoscopic standard limb Roux and Y gastric bypass
  • BMI < 32 kg/m2
  • Stability of weight loss for at least 6 months
  • grade 3 abdominal deformity on the Pittsburgh scale

Exclusion Criteria:

  • Illiterate
  • Current smoking
  • Prior IV iron use in the last 3 months
  • Uncontrolled systemic diseases
  • Hemoglobin < 11 g/dL
  • Ferritin <11 ng/mL
  • Ferritin > 100 ng/mL
  • transferrin saturation <16%
  • transferrin saturation> 50%
  • B12 < 210 pg/mL
  • Folic Acid < 3.3 ng/mL
  • Albumin < 2 g/dL
  • C reactive protein> 5 mg/L
  • Prior Anaphylactic reaction to IV iron
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857011

Contacts
Contact: Juan-Carlos Montano-Pedroso 551139382493 juancmontano@gmail.com

Locations
Brazil
Federal University of São Paulo Recruiting
São Paulo, Brazil, 04024-002
Contact: Juan Carlos Montano-Pedroso, MD    551150888463    juancmontano@gmail.com   
Principal Investigator: Juan Carlos Moantano-Pedroso, MD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Juan-Carlos Montano-Pedroso, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Juan Carlos Montano Pedroso, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01857011     History of Changes
Other Study ID Numbers: ISAPA UNIFESP 01
Study First Received: May 8, 2013
Last Updated: May 17, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Anemia, Iron-Deficiency
bariatric surgery
abdominoplasty
surgery, plastic
iron

Additional relevant MeSH terms:
Weight Loss
Anemia, Iron-Deficiency
Anemia
Body Weight Changes
Body Weight
Signs and Symptoms
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric oxide, saccharated
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014