Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Indiana University.
NCT02404012 is a NA study that has completed, run by Indiana University. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Ferritin, TIBC, sTfR
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 |
What the finished NCT02404012 record still lists
NCT02404012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Oral iron supplementation is the first listed.
NCT02404012 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02404012's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia