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Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268849
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michael Auerbach MD, Auerbach Hematology Oncology Associates P C

Brief Summary:

Given the limited long-term effectiveness of traditional weight loss methods, bariatric surgery is increasingly becoming the preferred option for sustained weight loss. With the ascendancy of the laparoscopic approach, the two most common procedures are the Roux-en-Y gastric bypass (RYGB) and the vertical sleeve gastrectomy (VSG).

Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient.

The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for its caustic effects on the gastric mucosa causing gastric irritation, nausea, epigastric discomfort and constipation. These debilitating symptoms lead to poor adherence and lower long and short-term efficacy. Furthermore, iron absorption from oral iron supplements when taken with food in patients with low iron stores ranges from 2 to 13% and without food 5 to 28%. An alternative and more effective method of iron replenishment is the use of intravenous iron. A litany of published trials, without contradiction, show marked superiority of intravenous iron in improving hemoglobin concentrations and iron parameters when compared to historical controls. Nonetheless, the current recommendations of the American Society of Metabolic and Bariatric Surgery nutritional guidelines, state that oral iron supplementation for IDA is the recommended first line of treatment. Studies are lacking that compare the efficacy of oral versus intravenous (IV) iron therapy for the treatment of IDA in the post-bariatric surgical patient.

The aim of our study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of IDA in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.

The primary outcome will be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify (based on inclusion/exclusion criteria), have an open-label IV iron treatment and will be followed with the same evaluations used after the first IV iron treatments.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferumoxytol Drug: Saline Drug: Ferrous sulfate tablets Drug: Vitamin C Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, double dummy of oral versus intravenous iron for iron deficiency patients after bariatric surgery. All subjects will get either oral iron and intravenous saline, or oral vitamin C and intravenous iron.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients will wear sleep masks to blind intravenous intervention
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
Estimated Study Start Date : February 17, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Oral Iron
The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.
Drug: Ferumoxytol
Ferumoxytol (30 mg/mL) intravenous injection in single use vials.

Drug: Saline
Placebo for Ferumoxytol

Drug: Ferrous sulfate tablets
ferrous sulfate tablets containing 60 mg elemental iron

Drug: Vitamin C
Placebo: Vitamin C, 250 mg, given in the same bottle as the oral iron

Active Comparator: IV Iron
The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.
Drug: Ferumoxytol
Ferumoxytol (30 mg/mL) intravenous injection in single use vials.

Drug: Saline
Placebo for Ferumoxytol

Drug: Ferrous sulfate tablets
ferrous sulfate tablets containing 60 mg elemental iron

Drug: Vitamin C
Placebo: Vitamin C, 250 mg, given in the same bottle as the oral iron




Primary Outcome Measures :
  1. Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins. [ Time Frame: 6 weeks ]
    The CGI-2 is a measure of treatment response and the efficacy of the treatment based on a 1 to 7 scale where 1 is "very much better" and 7 "very much worse"

  2. Change in hemoglobin concentration [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in ferritin > 20% [ Time Frame: 6 weeks ]
  2. Change in Transferrin saturation (TSAT) >19% [ Time Frame: 6 weeks ]
  3. Quality of Life by visual linear analog scale (LASA) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Aged ≥ 18 years
  2. Patients who have undergone a Roux-en Y Gastric Bypass or Vertical Sleeve Gastrectomy and are at least 3 months or more out from surgery.
  3. Iron deficiency anemia defined as iron deficient with either ferritin<30 mcg/l, TSAT<20%, or anemia with Hgb<13 g/dL for both males and females.
  4. Willingness to participate and signing the informed consent form.

Exclusion criteria:

  1. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
  2. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
  3. Serum ferritin > 400 ng/mL or transferrin saturation >40 %
  4. Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
  5. Rheumatoid arthritis with symptoms or signs of active inflammation
  6. Pregnant and nursing women
  7. History of multiple allergies (two or more)
  8. Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products
  9. Previous IV iron treatment for IDA
  10. Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
  11. Planned elective surgery during the study
  12. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus

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): NCT04268849


Contacts
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Contact: Michael Auerbach, MD 4107804050 mauerbachmd@abhemonc.com
Contact: Stella Rineer, RN 410 7804050 srineer@yahoo.com

Locations
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United States, Maryland
Auerbach Hematology and Oncology
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
Auerbach Hematology Oncology Associates P C
AMAG Pharmaceuticals, Inc.

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Responsible Party: Michael Auerbach MD, Principal Investigator, Auerbach Hematology Oncology Associates P C
ClinicalTrials.gov Identifier: NCT04268849    
Other Study ID Numbers: BariatricsProtocol100719
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Auerbach MD, Auerbach Hematology Oncology Associates P C:
Bariatric Surgery
Roux-en-Y gastric bypass (RYGB)
Vertical Sleeve Gastrectomy (VSG)
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Vitamins
Ascorbic Acid
Iron
Ferrosoferric Oxide
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions