Iron Supplement to Improve Iron Status Following Bariatric Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | November 2014 |
| Contact: | Nana G MIller, PhD |
| Email: | ngletsum@purdue.edu |
| Phone: | 7654969462 |
Comparison of Iron Supplement Formulations to Improve Iron Status Following Roux-en-Y and Sleeve Gastrectomy Bariatric Surgery
There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and
effective therapies are lacking. Thus, there is a critical need for an effective,
non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and
improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric
surgery patient population. Often, patients do not participate in bariatric programs, are
not compliant, and/or are lost to follow-up. If there is a more effective and evidence-based
guideline for repletion of iron deficiency, patients are more likely to be compliant.
Therefore, in a randomized controlled study, the investigators propose to test the
effectiveness of HIP versus ferrous sulfate for oral iron supplementation of iron deficient
patients who have had RYGB or SG bariatric surgery. By randomizing patients into the two
groups, the investigators will be able to determine the most effective regimen to improve
blood biomarkers of iron status, cognitive function, and quality of life. Other outcomes
will include adverse effects and compliance to the supplementation. The investigators will
also analyze three-day food records to determine the contribution of dietary factors to
changes in iron status. To test for improvement of iron status, serial blood draws will be
performed during a time period of ~10 weeks. Serial blood draws from iron deficient patients
have routinely been performed in past studies and have not been found to be harmful. Because
this is a relatively short study (10 weeks), subjects will be able to recover quickly from
the blood loss during the study. the investigators expect to find that iron supplementation
with HIP will be more effective than ferrous sulfate for repletion of iron deficiency. This
project will address a significant health issue in individuals who have had bariatric
surgery, which is a growing population in the United States. It is estimated that almost 1.5
million individuals have undergone bariatric surgery since the year 1990.
effective therapies are lacking. Thus, there is a critical need for an effective,
non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and
improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric
surgery patient population. Often, patients do not participate in bariatric programs, are
not compliant, and/or are lost to follow-up. If there is a more effective and evidence-based
guideline for repletion of iron deficiency, patients are more likely to be compliant.
Therefore, in a randomized controlled study, the investigators propose to test the
effectiveness of HIP versus ferrous sulfate for oral iron supplementation of iron deficient
patients who have had RYGB or SG bariatric surgery. By randomizing patients into the two
groups, the investigators will be able to determine the most effective regimen to improve
blood biomarkers of iron status, cognitive function, and quality of life. Other outcomes
will include adverse effects and compliance to the supplementation. The investigators will
also analyze three-day food records to determine the contribution of dietary factors to
changes in iron status. To test for improvement of iron status, serial blood draws will be
performed during a time period of ~10 weeks. Serial blood draws from iron deficient patients
have routinely been performed in past studies and have not been found to be harmful. Because
this is a relatively short study (10 weeks), subjects will be able to recover quickly from
the blood loss during the study. the investigators expect to find that iron supplementation
with HIP will be more effective than ferrous sulfate for repletion of iron deficiency. This
project will address a significant health issue in individuals who have had bariatric
surgery, which is a growing population in the United States. It is estimated that almost 1.5
million individuals have undergone bariatric surgery since the year 1990.
Objectives:
1. To determine the most effective oral iron supplementation regimen for repletion of iron
deficiency in patients who have had gastric bypass or sleeve gastrectomy. In iron
deficient patients, two supplement regimens will be compared:
1. Ferrous sulfate 65 mg t.i.d. (standard of care / control), which is elemental iron
2. Proferrin ES 12 mg t.i.d., which is heme-iron polypeptide.
Primary outcomes will be reference indices of iron status:
- Ferritin, TIBC, sTfR, and sTfR:ferritin ratio
- Secondary outcomes will be:
- measures of anemia, determined by blood hemoglobin concentrations
- measures of cognitive function via several computerized tests on working memory,
sustained attention, and spatial memory
- fatigue by Multidimensional Fatigue Inventory questionnaire
- Quality of life by SF-36 Survey
Safety outcomes will be:
• adverse events, compliance, measures of iron toxicity, and liver enzymes
2. In the same subjects undergoing iron supplementation described in Aim 1, to determine
the contribution of dietary factors (including heme and non-heme iron intake, and
intake of enhancers and inhibitors of iron absorption) to changes in iron status.
1. To determine the most effective oral iron supplementation regimen for repletion of iron
deficiency in patients who have had gastric bypass or sleeve gastrectomy. In iron
deficient patients, two supplement regimens will be compared:
1. Ferrous sulfate 65 mg t.i.d. (standard of care / control), which is elemental iron
2. Proferrin ES 12 mg t.i.d., which is heme-iron polypeptide.
Primary outcomes will be reference indices of iron status:
- Ferritin, TIBC, sTfR, and sTfR:ferritin ratio
- Secondary outcomes will be:
- measures of anemia, determined by blood hemoglobin concentrations
- measures of cognitive function via several computerized tests on working memory,
sustained attention, and spatial memory
- fatigue by Multidimensional Fatigue Inventory questionnaire
- Quality of life by SF-36 Survey
Safety outcomes will be:
• adverse events, compliance, measures of iron toxicity, and liver enzymes
2. In the same subjects undergoing iron supplementation described in Aim 1, to determine
the contribution of dietary factors (including heme and non-heme iron intake, and
intake of enhancers and inhibitors of iron absorption) to changes in iron status.
Inclusion Criteria:
- Subject has a history of RYGB or SG weight loss surgery at least 6 months ago
- Subject meets at least 2 of the 4 previously mentioned conditions classifying them as
iron deficient
- Subject is female
- Subject is at least 18 but not more than 50 years of age (post-menopausal status is
an exclusion criteria)
- Subject has signed an informed consent.
Exclusion Criteria:
- Subject is pregnant
- Subject has history of surgical revision or conversion of bariatric procedure
- Subject is under a treatment regimen that requires iron supplementation greater than
standard of care
- Subject has had parenteral iron less than one month before screening visit
- Subject has extremely heavy menstruation
- Subject has a history of hospitalization for acute illness in the previous 3 months
- Subject has current active malignant neoplasm; or history of malignancy other than
localized basal cell cancer of skin during previous 5 years
- Subject has gastrointestinal disease that involve increased inflammation or blood
loss (e.g. Crohn's disease, Ulcerative colitis)
- Subject is post-menopausal
- Subject has severe anemia, with a hemoglobin > 7.0 g/dL (subjects will be notified of
their results)
- Subject is taking an erythropoietin stimulating medication or is on hemodialysis.
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