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Iron Supplement to Improve Iron Status Following Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02404012
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Nana Gletsu-Miller, Purdue University

Brief Summary:
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 various iron formulations versus ferrous sulfate, which is the standard of care, 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 organic formulations of iron will be as effective than ferrous sulfate for repletion of iron deficiency, and they will be better tolerated. 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.

Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Dietary Supplement: Oral iron supplementation Not Applicable

Detailed Description:

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. AspironTM, which is an organic formulation of iron

    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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Iron Supplement Formulations to Improve Iron Status Following Roux-en-Y and Sleeve Gastrectomy Bariatric Surgery
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: Ferrous sulfate
Ferrous sulfate 65 mg. t.i.d is the standard of care for oral supplementation for iron deficiency
Dietary Supplement: Oral iron supplementation
Participants will be provided supplementation for 8 weeks

Experimental: AspironTM 65 mg t.i.d.
AspironTM, an organic formulation of iron, is the experimental treatment for oral supplementation of iron deficiency
Dietary Supplement: Oral iron supplementation
Participants will be provided supplementation for 8 weeks




Primary Outcome Measures :
  1. Iron status [ Time Frame: 8 weeks ]
    Ferritin, TIBC, sTfR


Secondary Outcome Measures :
  1. Anemia assessed by Hemoglobin concentrations [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Safety outcomes assessed by adverse events, compliance [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 65 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404012


Contacts
Contact: Nana G MIller, PhD 7654969462 ngletsum@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47906
Contact: Nana Gletsu Miller, Ph.D.    765-496-9462    ngletsum@purdue.edu   
Principal Investigator: Nana Gletsu, Ph.D.         
Sponsors and Collaborators
Purdue University

Study Data/Documents: Website  This link exits the ClinicalTrials.gov site

Responsible Party: Nana Gletsu-Miller, Assitant Prof. Nutrition Sciences, Purdue University
ClinicalTrials.gov Identifier: NCT02404012     History of Changes
Other Study ID Numbers: IRB1410015305
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Nana Gletsu-Miller, Purdue University:
iron deficiency
sleeve gastrectomy
gastric bypass
bariatric surgery

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs