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NCT02404012 · ClinicalTrials.gov registry record · NA
Iron Supplement to Improve Iron Status Following Bariatric Surgery
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT02404012 is a NA study that has completed, run by Indiana University. The registered enrollment target is 64 participants.
The verdict
NCT02404012, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study 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 surge
Interventions
- DIETARY_SUPPLEMENT Oral iron supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2014-11 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02404012
The ClinicalTrials.gov registry entry for NCT02404012 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral iron supplementation is the first listed.
NCT02404012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02404012 about?
NCT02404012 is a clinical study titled "Iron Supplement to Improve Iron Status Following 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 cogn...
What is the current status of trial NCT02404012?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2014-11. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT02404012?
The interventions under investigation include: Oral iron supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02404012?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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