Comparison of Iron Supplement Formulations to Improve Iron Status Following Roux-en-Y and Sleeve Gastrectomy Bariatric Surgery

Investigating Iron Supplementation for Bariatric Surgery Patients

Recruiting
18 years - 65 years
Female
Phase N/A
1 Location

Brief description of study.

The study team would like to learn the best form of over-the-counter iron supplementation for bariatric surgery patients who develop iron deficiency.

Detailed description of study

The purpose of this study is to determine the effectiveness of various novel iron formulations versus ferrous sulfate for oral iron supplementation of iron deficient patient who have had RYGB or SG bariatric surgery.

This study takes place in Indianapolis, IN and West Lafayette, IN.

Participants will be compensated for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: iron deficency,bariatric surgery
  • Age: 18 years - 65 years
  • Gender: Female

Inclusion Criteria
Has a history of RYGB or SG bariatric surgery at least 6 months ago
Meets study conditions of being iron deficient
Exclusion Criteria
Pregnant
Currently under a treatment regiment that requires iron supplementation greater than standard of care
Has had parenteral iron less than one month before screening visit
Has history of hospitalization for acute illness in the previous one month
Has current active malignant neoplasm or history of malignancy other than localized basal cell cancer of skin during previous 5 years, and advice from oncologist that discourages them from participating in the the study
Has gastrointestinal disease that involves increased inflammation or blood loss
Has severe anemia
Taking erythropoietin stimulating medication or is on hemodialysis

Updated on 19 Feb 2024. Study ID: 1504248809

This study investigates the effectiveness of different types of over-the-counter iron supplements for patients who have undergone bariatric surgery and are experiencing iron deficiency. Bariatric surgery includes procedures like Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), which can sometimes lead to iron deficiency. The study compares various new iron formulations with ferrous sulfate to see which works best for these patients.

Participants in the study will take oral iron supplements and their progress will be monitored to see how well their iron levels improve. This involves taking different iron formulations and tracking their effectiveness. The study does not involve any invasive procedures and focuses on the oral intake of supplements.

  • Who can participate: Adults who have had RYGB or SG bariatric surgery at least 6 months ago and are iron deficient can participate. Exclusions include those who are pregnant, have severe anemia, or have had parenteral iron recently, among other criteria.
  • Study details: Participants will take different oral iron supplements as part of the study. Some will receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

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