Iron Supplement to Improve Iron Status Following Bariatric Surgery

NCT02404012 | Completed

• 1 other identifier: IRB1410015305
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 surgery, which is a growing population in the United States. It is estimated that almost 1.5 million individuals have undergone bariatric surgery since the year 1990.

Conditions

Anemia, Iron Deficiency

Keywords

iron deficiency; sleeve gastrectomy; gastric bypass; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Iron status

  Ferritin, TIBC, sTfR

  8 weeks

Secondary Outcomes (1)

• Anemia assessed by Hemoglobin concentrations

  8 weeks

Other Outcomes (1)

• Safety outcomes assessed by adverse events, compliance

  8 weeks

Study Arms (2)

Ferrous sulfate

ACTIVE COMPARATOR

Ferrous sulfate 65 mg. t.i.d is the standard of care for oral supplementation for iron deficiency

Dietary Supplement: Oral iron supplementation

AspironTM 65 mg t.i.d.

EXPERIMENTAL

AspironTM, an organic formulation of iron, is the experimental treatment for oral supplementation of iron deficiency

Dietary Supplement: Oral iron supplementation

Interventions

Oral iron supplementation DIETARY_SUPPLEMENT

Participants will be provided supplementation for 8 weeks

AspironTM 65 mg t.i.d.; Ferrous sulfate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a history of RYGB or SG weight loss surgery at least 6 months ago
• Subject meets at least 2 of the 4 previously mentioned conditions classifying them as iron deficient
• Subject is female

You may not qualify if:

• Subject has signed an informed consent.
• Subject is pregnant
• Subject has history of surgical revision or conversion of bariatric procedure
• Subject is under a treatment regimen that requires iron supplementation greater than standard of care
• Subject has had parenteral iron less than one month before screening visit
• Subject has extremely heavy menstruation
• Subject has a history of hospitalization for acute illness in the previous 3 months
• Subject has current active malignant neoplasm; or history of malignancy other than localized basal cell cancer of skin during previous 5 years
• Subject has gastrointestinal disease that involve increased inflammation or blood loss (e.g. Crohn's disease, Ulcerative colitis)
• Subject is post-menopausal
• Subject has severe anemia, with a hemoglobin \> 7.0 g/dL (subjects will be notified of their results)
• Subject is taking an erythropoietin stimulating medication or is on hemodialysis.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Prof. Nutrition Sciences

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

US (1)