Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

Iron Deficiency Clinical Trial

— Ironsuppletion  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271997
• Other study ID #: Ironsuppletion
• Status: Completed
• Phase: Phase 4
• Start date: December 4, 2014
• Est. completion date: June 6, 2017

Study information

• Verified date: January 2019
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.

Description:

Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.

Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.

Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin<20microgram/L)

Exclusion Criteria:

• iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Drug:
• Ferrous fumarate
treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
• Ferrous gluconate
treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
• Iron(III)carboxymaltose
treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured

Locations

Country	Name	City	State
Netherlands	OLVG West/ Sint Lucas Andreas Ziekenhuis	Amsterdam	Noord-Holland
Netherlands	Rijnstate hospital	Arnhem
Netherlands	Rose Kruis Ziekenhuis	Beverwijk

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normal value serum ferritin	1 year after initiating therapy	1 year
Secondary	patients preference for oral or intravenous therapy		1 year