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NCT04268849 · ClinicalTrials.gov registry record · Phase 3
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
A Phase 3 study of Iron Deficiency Anemia, sponsored by Auerbach Hematology Oncology Associates P C.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT04268849 is a Phase 3 study of Iron Deficiency Anemia that is actively recruiting participants, run by Auerbach Hematology Oncology Associates P C. The registered enrollment target is 104 participants, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04268849, a Phase 3 study of Iron Deficiency Anemia, is actively recruiting participants, sponsored by Auerbach Hematology Oncology Associates P C.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study 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 deficien
Conditions Studied
Interventions
- DRUG Ferumoxytol
- DRUG Saline
- DRUG Ferrous sulfate tablets
- DRUG Vitamin C
Study Locations (1)
Maryland
- Auerbach Hematology and Oncology - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2026-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04268849
The ClinicalTrials.gov registry entry for NCT04268849 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (45% lower). The listed sponsor is Auerbach Hematology Oncology Associates P C, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 4 interventions - of which Ferumoxytol is the first listed.
NCT04268849 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04268849 about?
NCT04268849 is a clinical study titled "Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient". 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 ve...
What is the current status of trial NCT04268849?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2020-02-27. Estimated completion is 2026-02.
What conditions does trial NCT04268849 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia.
What interventions are being tested in trial NCT04268849?
The interventions under investigation include: Ferumoxytol (DRUG), Saline (DRUG), Ferrous sulfate tablets (DRUG), Vitamin C (DRUG).
Who is sponsoring clinical trial NCT04268849?
This trial is sponsored by Auerbach Hematology Oncology Associates P C, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04268849 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
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