Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
OLVG West/ Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, Netherlands
Rijnstate hospital
Arnhem, Netherlands
Rose Kruis Ziekenhuis
Beverwijk, Netherlands
normal value serum ferritin
1 year after initiating therapy
Time frame: 1 year
patients preference for oral or intravenous therapy
Time frame: 1 year
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