Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02404012
Other study ID # IRB1410015305
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date December 31, 2021

Study information

Verified date August 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Objectives: 1. To determine the most effective oral iron supplementation regimen for repletion of iron deficiency in patients who have had gastric bypass or sleeve gastrectomy. In iron deficient patients, two supplement regimens will be compared: 1. Ferrous sulfate 65 mg t.i.d. (standard of care / control), which is elemental iron 2. AspironTM, which is an organic formulation of iron Primary outcomes will be reference indices of iron status: - Ferritin, TIBC, sTfR, and sTfR:ferritin ratio - Secondary outcomes will be: - measures of anemia, determined by blood hemoglobin concentrations - measures of cognitive function via several computerized tests on working memory, sustained attention, and spatial memory - fatigue by Multidimensional Fatigue Inventory questionnaire - Quality of life by SF-36 Survey Safety outcomes will be: • adverse events, compliance, measures of iron toxicity, and liver enzymes 2. In the same subjects undergoing iron supplementation described in Aim 1, to determine the contribution of dietary factors (including heme and non-heme iron intake, and intake of enhancers and inhibitors of iron absorption) to changes in iron status.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date December 31, 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 - Subject is at least 18 but not more than 65 years of age (post-menopausal status is an exclusion criteria) - Subject has signed an informed consent. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Oral iron supplementation
Participants will be provided supplementation for 8 weeks

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety outcomes assessed by adverse events, compliance 8 weeks
Primary Iron status Ferritin, TIBC, sTfR 8 weeks
Secondary Anemia assessed by Hemoglobin concentrations 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT04435574 - Lactoferrin for Treatment of Iron Deficiency Anemia. Phase 4
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Not yet recruiting NCT05050851 - Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04626414 - Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers Phase 1
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Recruiting NCT05304442 - IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department Phase 3
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Completed NCT05047211 - Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia Phase 4
Not yet recruiting NCT06061393 - Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia Phase 4
Completed NCT05190263 - Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma
Completed NCT03318055 - Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients
Completed NCT04631679 - Investigation of the Wash-out Effect of Intravenous Iron by Cell Savers (WASH-OUT)
Recruiting NCT05225545 - Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis Phase 3
Recruiting NCT03347513 - Eradication of H-pylori in Pregnancy and Its Effect on Iron Replacement Therapy? Phase 4
Recruiting NCT04708665 - Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India
Completed NCT04137354 - Iron and Vitamin A in School Children N/A
Not yet recruiting NCT06096103 - A Clinical Study to Check the Safety and Effectiveness of Botanical Extract Standardized for Iron + Vitamin c and Botanical Extract Standardized for Iron in Adult Human Subjects With Anemia or Iron-deficiency Anemia N/A
Completed NCT03156712 - Iron Absorption From Iron-enriched Aspergillus Oryzae N/A
Completed NCT05522790 - Impact of Iron Infusion in Anemic Patients on Their Postoperative Outcome After Colorectal Surgery