Status:
COMPLETED
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty
Lead Sponsor:
Federal University of São Paulo
Conditions:
Anemia, Iron-Deficiency
Weight Loss
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
Brief Summary
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 abdominopla...
Detailed Description
Multicenter open randomized clinical trial with allocation ratio 1: 1. 56 adult patients undergoing post- bariatric abdominoplasty will be evaluated. The study group will receive 200 mg of intravenous...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01857011
Start Date
April 1 2014
End Date
June 1 2016
Last Update
January 24 2017
Active Locations (1)
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1
Federal University of São Paulo
São Paulo, São Paulo, Brazil, 04024-002