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New treatment option for Iron Deficiency
Official title Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35
ClinicalTrials.gov ID: NCT06942208
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are: Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 35, women only. Healthy volunteers may be eligible.
You may be able to join if
- Biologically female athlete
- Age 16-35
- At least one year past the age of menarche
- Complete and pass the Get Active Questionnaire (GAQ)
- Suboptimal ferritin levels (≤50 mcg/L)
You likely can't join if
- Non-English speaking
- Anemic (hemoglobin \<120g/L)
- Regular prebiotic (fiber) or probiotic use within 4 weeks of study enrollment
- Current laxative use
- Are a smoker or use tobacco products
- Consume \>21 units of alcohol per week
See the full eligibility criteria
Who can join
- Biologically female athlete
- Age 16-35
- At least one year past the age of menarche
- Complete and pass the Get Active Questionnaire (GAQ)
- Suboptimal ferritin levels (≤50 mcg/L)
- Provide informed consent to participate in study
- Activity level based on Participant Classification Framework (McKay et al., 2022)
- Tier 3: Highly Trained / National Level
- Tier 4: Elite / International Level
- Energy availability \>30 kcal/kg LBM
- Have access to a smartphone, tablet, or computer
- Able to swallow a capsule sized 25mm length and 8mm width (i.e. large dose omega 3 pill)
What rules you out
- Non-English speaking
- Anemic (hemoglobin \<120g/L)
- Regular prebiotic (fiber) or probiotic use within 4 weeks of study enrollment
- Current laxative use
- Are a smoker or use tobacco products
- Consume \>21 units of alcohol per week
- Have donated blood in the previous 3 months
- Have a BMI \ 30kg/m2
- Are dieting for weight loss or are following a low carbohydrate diet
- Have participated in another clinical trial within the 30 days preceding study enrollment.
- Known allergy of hypersensitivity to any ingredient, including non-medicinal ingredients, such as iron, yeast, cellulose, or maltodextrin
- Are taking medications known to affect cardiovascular or metabolic responses to exercise such as beta-blockers, anti-coagulants etc. as assessed by the Principal Investigator
- Known history of thalassemia or thalassemia trait
- Known inherited bleeding disorder
- Major surgery in the past 3 months
- Chronic use of Salicylates, aspirin, corticosteroids, or nonsteroidal anti-inflammatory drugs
- Have any of the following conditions: renal or gastrointestinal disorders, autoimmune disease, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood...
- Have current musculoskeletal injuries that limit exercise capacity
- Self-identifying with any kidney or gastrointestinal issues, metabolic disorders, cardiac conditions, vascular illnesses, rheumatoid arthritis, diabetes, compromised lung function, unregulated blood pressure, episodes...
- Orthopaedic issues that limit exercise ability
- Currently/last 3 months taking prescription medications that are known to affect iron absorption (i.e. Antacids/PPIs (e.g., omeprazole), H2 Blockers (e.g., ranitidine), Tetracycline Antibiotics (e.g., doxycycline)...
- Currently taking levodopa or levothyroxine
- Currently/last 3 months taking iron containing supplements
- Are pregnant or lactating or planning to become pregnant for the duration of the study. All participants must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth...
- Abstinence or agrees to use contraception if planning to become sexually active
- Hormonal contraceptives including oral contraceptives, hormone birth control patch
- Vaginal contraceptive ring, injectable contraceptives, or hormone implant
- Barrier methods (e.g. condoms with spermicide, diaphragms with spermicide)
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening Additional exclusion criteria based on use of SIMBA capsules. Following is a summary of SIMBA capsules specific exclusion criteria:
- Currently pregnant, planning to become pregnant, or breastfeeding
- Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring, narrowing, or obstruction with a risk of capsule non-excretion, including, e.g...
- History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction
- Have any gastrointestinal inflammatory diseases, including ulcerative colitis, Crohn's disease, microscopic colitis.
- Use of any medication in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, GLP-1...
- Prokinetic (stimulate muscle contractions, Metoclopramide, Domperidone, Prucalopride, etc.) use. If you are not using prokinetics to treat SIBO, then you may be eligible after a 2-week washout period, and willing to not...
- Unable to stop using laxatives or prokinetic medications for 4 days before the study procedure (breath test). Laxatives can be resumed after the test is conducted.
- Have used antibiotics (except for topical use) in the previous 12 weeks. You may be eligible to participate once a 12-week washout is completed
- Regular use of probiotics, prebiotics, or synbiotics (including food and drinks containing added probiotics and/or probiotic yogurts with live, active cultures)
- Have digestive problems that slow or stop food from moving properly, like a slow stomach, blocked intestines, or stiffened tissues
- Suffer from celiac disease (treated or untreated)
- Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration
- Have had a cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable)
- Have trouble swallowing, which could cause a risk of choking on a capsule
- Participants scheduled for an MRI at any time during the study. You may be eligible to participate once your MRI procedure is completed.
- Have constant constipation (IBS-C) defined as a history of less than 3 bowel movements per week
- Any prior fecal microbiota transplantation
- Drug use
- Suffer from alcohol or drug abuse
- Females of childbearing potential will be asked about their likelihood of being pregnant, based on factors such as recent sexual activity or use of contraception. Their self-reported confirmation of non-pregnancy will...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.