Anemia, Iron-DeficiencyPhase 3ISAPANCT01857011
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty
A Phase 3 study testing Intravenous Iron sucrose and Oral Iron in people with Anemia, Iron-Deficiency and Weight Loss, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Anemia, Iron-Deficiency, Weight Loss
- What is being tested?
- Intravenous Iron sucrose and Oral Iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Illiterate
- Current smoking
- Prior IV iron use in the last 3 months
- Uncontrolled systemic diseases
- Hemoglobin < 11 g/dL
- Ferritin <11 ng/mL
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial
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 .
- Conditions
- Anemia, Iron-Deficiency, Weight Loss
- Being tested
- Intravenous Iron sucrose, Oral Iron
- Keywords
- Anemia, Iron-Deficiency, bariatric surgery, abdominoplasty, surgery, plastic, iron
- Medical subject headings
- Anemia, Iron-Deficiency, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Iron sucroseDrug
Also called Noripurum
Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
Oral IronDrug
Also called Noripurum
Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
| Study group | Role | What they receive |
|---|---|---|
| IV Iron | Experimental | Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop. Receives: Drug: Intravenous Iron sucrose |
| Oral Iron | Active comparator | Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks. Receives: Drug: Oral Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Hemoglobin level measured at 8 postoperative weeks
Measured: 8 postoperative weeks
Secondary outcomes (5)
Ferritin levels
Measured: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
FACIT
The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.
Measured: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
SF36
Quality of Life Questionnaire
Measured: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Transferrin saturation
Measured: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Hemoglobin levels
Measured: preoperative (one day before surgery) and 1, 4 postoperative weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Carlos Montano Pedroso, Federal University of São Paulo
- Investigators
- Juan-Carlos Montano-Pedroso, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857011
- Sponsor's protocol ID
- ISAPA UNIFESP 01
- Acronym
- ISAPA
- Status last verified
- Jan 2017
- First submitted
- 8 May 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 29958570Montano-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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01857011
- Acronym / sponsor ID
- ISAPA / ISAPA UNIFESP 01
- Conditions
- Anemia, Iron-Deficiency, Weight Loss
- Keywords
- Anemia, Iron-Deficiency, bariatric surgery, abdominoplasty, surgery, plastic, iron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Iron | Experimental | Drug: Intravenous Iron sucroseIntravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop. |
| Oral Iron | Active comparator | Drug: Oral IronOral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Illiterate
- Current smoking
- Prior IV iron use in the last 3 months
- Uncontrolled systemic diseases
- Hemoglobin < 11 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Iron sucroseAlso: NoripurumIntravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop. | Drug | IV Iron |
| Oral IronAlso: NoripurumOral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks. | Drug | Oral Iron |
Primary outcome
Hemoglobin level
Time frame: 8 postoperative weeks
Hemoglobin level measured at 8 postoperative weeks
5 secondary outcomes
Ferritin levels
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
FACIT
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
SF36
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Transferrin saturation
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Hemoglobin levels
Time frame: preoperative (one day before surgery) and 1, 4 postoperative weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Derived from this study: PubMed 29958570Montano-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.
- Derived from this study: PubMed 27068478Montano-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan-Carlos Montano-Pedroso, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Iron sucrose and Oral Iron in people with Anemia, Iron-Deficiency and Weight Loss, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: 8 postoperative weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01857011, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.