Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers
Completed · Not applicable · Has a placebo group
Conditions studied: Iron
In brief
Iron deficiency-related anemia is the most common nutritional deficiency disorder in the world, mainly affecting children, women and older adults in underdeveloped countries. To combat iron deficiency, inorganic forms of iron (such as ferrous sulfate) are often used as an iron supplement. One big problem is that high levels of this kind of iron supplement produce negative health effects. This includes diarrhea, changes in the bacteria in the gut, as well as increased severity to malaria in young children in countries with high rates of that parasite. Most forms of iron are not well absorbed and, therefore, pass through the intestine to be eliminated in the stool. This unabsorbed iron can be used by gut bacteria, disturbing the balance of healthful and potentially harmful bacteria in the colon, which can increase inflammation in the body. In this study, the investigators are seeking to determine whether two new forms of iron cause fewer changes in the gut bacteria thus lowering inflammation while providing similar amounts of iron to the body. The findings from this research study are important because they will inform the development of safer treatments for iron deficiency.
Key facts
- Study ID
- NCT03212677
- Run by
- Tufts University
- People needed
- 226
- Starts
- 2017-05-17
- Expected to finish
- 2022-07-30
- Last updated by the study team
- 2025-04-25
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age range: 50-80 years
- BMI range: 18-35
- Men and post-menopausal women (defined as no menses for > 1year or S/P hysterectomy with bilateral oopherectomy)
- Typical bowel pattern: at least 1 stool every other day
- Willing to take iron and be randomized into study intervention group
- Willing to abstain from recreational drug use and consumption > 2 alcoholic drinks per day during study participation
- Will not be undergoing colonoscopy in the 2 months before, or during the course of the study
You may not qualify if…
- Any major illness or condition that may interfere with study outcomes at the discretion of the study MD
- Personal history of G-6-P (glucose-6-phosphate dehydrogenase) deficiency
- Diabetes Type 1 \& Type 2 or use of any pharmacological treatment for diabetes
- Endocrine disorders including diabetes, unstable thyroid disease (dose adjustment of thyroid replacement in the past 6 months), adrenal disease, pheochromocytoma or parathyroid disease
- Recent history of inflammatory diseases (for example: rheumatoid arthritis, lupus)
- Use tumor necrosis factor (TNF) blockade medication, methotrexate, or other immune-modulating drugs
- Steroid use (except for non-prescription topical and nasal steroids, e.g. Flonase)
- If participant is on hormone replacement therapy with estrogen, testosterone or growth hormone, has the dosage regimen changed in the past month, or expected to change during course of study
- History of myocardial infarction, stroke or transient ischemic attack (TIA), coronary artery bypass graft, stenosis >50% diagnosed within the past 1 year or acute unstable cardiovascular disease.
- Clotting/bleeding disorders or ongoing anticoagulant use: coumadin (warfarin), Eliquis, Xarelto, Pradaxa
- GI diseases, conditions or medications known to influence GI absorption including active peptic ulcer disease or inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), pancreatic insufficiency, celiac disease, malabsorption disorders (other than lactose intolerance)
- Hx of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure
- Regular use (> 2 times per week) of acid lowering medication: antacids, proton pump inhibitors (PPI), H2 blockers
- History of eating disorder anorexia, bulimia or binge-eating in the past 5 years
- Actively undergoing dialysis
- Inadequately controlled hypertension (HTN) @ the discretion of study MD or Registered Nurse
- Certain psychiatric disorders including schizophrenia, bipolar major depression or psychosis (depression OK, if stable on treatment regimen for > 6 months)
- Immunodeficiency condition, HIV or AIDS
- Cancer of any type (except for non-melanoma skin) in past year
- Actively using cancer chemotherapeutic agents
- Regular use of acetylsalicylic acid (ASA); NSAIDs; Cox-2 inhibitors. However, infrequent NSAID use (not on a regular scheduled basis) allowed if able to hold NSAIDs x 72 hours prior to all blood draws
- Infection or febrile illness within 2wks prior to study or study blood draws, may rescheduled >2wks after resolution of symptoms
- Hx of malaria; or vaccination or treatment for malaria, or antimalarial prophylaxis in past 3 months
- Seizure disorders (OK if well managed with medication: no seizure activity x 3 yrs)
- Hx splenectomy
Where it is running
- Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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