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CompletedNCT01857011ISAPAUpdated Jan 24, 2017

Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

A Phase 3 interventional study of Intravenous Iron sucrose and Oral Iron in Anemia, Iron-Deficiency and Weight Loss, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-01-24.

Sponsored by Federal University of São Paulo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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 abdominoplasty.

Read the 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 iron in the immediate postoperative period and a second application on day 1 postoperatively. The control group will receive 100 mg of oral iron twice daily for 8 weeks. Haematological variables , iron 's profile , quality of life ( SF -36 and FACT- An) and adverse events will be assessed preoperatively and on the first , fourth and eighth weeks postoperatively .

02

Conditions studied

  • Anemia, Iron-Deficiency
  • Weight Loss

Keywords

  • Anemia, Iron-Deficiency
  • bariatric surgery
  • abdominoplasty
  • surgery, plastic
  • iron
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 56 is below the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • 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

Interventions

  • DrugIntravenous Iron sucrose

    Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.

    Also known as: Noripurum

  • DrugOral Iron

    Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.

    Also known as: Noripurum

06

What researchers measure

Primary outcomes

  1. Hemoglobin level

    Hemoglobin level measured at 8 postoperative weeks

    Time frame: 8 postoperative weeks

Secondary outcomes

  1. Ferritin levels

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

  2. FACIT

    The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

  3. SF36

    Quality of Life Questionnaire

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

  4. Transferrin saturation

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

  5. Hemoglobin levels

    Time frame: preoperative (one day before surgery) and 1, 4 postoperative weeks

07

Study locations

1 site
  • Federal University of São Paulo
    São Paulo, 04024-002, Brazil
08

References and documents

Publications

  • Montano-Pedroso JC, Bueno Garcia E, Alcantara Rodrigues de Moraes M, Francescato Veiga D, Masako Ferreira L. Intravenous iron sucrose versus oral iron administration for the postoperative treatment of post-bariatric abdominoplasty anaemia: an open-label, randomised, superiority trial in Brazil. Lancet Haematol. 2018 Jul;5(7):e310-e320. doi: 10.1016/S2352-3026(18)30071-1. PubMed 29958570 ↗
  • Montano-Pedroso JC, Garcia EB, Novo NF, Veiga DF, Ferreira LM. Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial. Trials. 2016 Apr 12;17:196. doi: 10.1186/s13063-016-1300-x. PubMed 27068478 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01857011
Lead sponsor
Federal University of São Paulo
Responsible party
Juan Carlos Montano Pedroso (MD, Federal University of São Paulo) — Principal investigator
First posted
May 20, 2013
Start date
Apr 2014
Primary completion
Apr 2016
Completion
Jun 2016
Last update
Jan 24, 2017

Study contacts

Juan-Carlos Montano-Pedroso, MD
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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