Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

Weight Loss Clinical Trial

— ISAPA  

Official title:

Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857011
• Other study ID #: ISAPA UNIFESP 01
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2013
• Last updated: January 23, 2017
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Weight Loss

Intervention

Drug:
• Intravenous Iron sucrose
Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
• Oral Iron
Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level	Hemoglobin level measured at 8 postoperative weeks	8 postoperative weeks
Secondary	Ferritin levels		Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Secondary	FACIT	The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.	Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Secondary	SF36	Quality of Life Questionnaire	Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Secondary	Transferrin saturation		Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Secondary	Hemoglobin levels		preoperative (one day before surgery) and 1, 4 postoperative weeks