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โ† Trials
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Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35

RecruitingNAAges 16 Years - 35 YearsFemaleUniversity of Calgary
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In plain words

What the trial is, and whether it could suit you

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? * Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms? * How do iron supplements affect exercise performance and gut bacteria? Researchers will compare three types of iron supplements: * A low-dose iron supplement (40 mg) * A low-dose yeast-bound iron supplement (40 mg) * A high-dose iron supplement (150 mg) This will help researchers find out which type of supplement is most effective and easiest on the stomach. Participants will: * Take one of the three assigned iron supplements every other day for 1

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 (โ‰ค50 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) Exclusion Criteria: * 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 \<16 but \>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 pressure, dizziness, thyroid problems, or any other health conditions that are being treated and deemed to be able to significantly interfere with study intervention and assessment in the opinion of the Principal Investigator and Qualified Investigator * 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 of dizziness, thyroid complications, or any other health conditions under treatment that might potentially interfere with the study results * 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), Quinolone Antibiotics (e.g., ciprofloxacin), Cholestyramine, Colchicine, Methyldopa.) * 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 control must have been in use for a minimum of three months. Acceptable methods of birth control include: * 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. achalasia, eosinophilic esophagitis, any IBD, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable. * 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 analogues); laxative use is allowed if it is kept unchanged in the week prior to the study visit. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter. * 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 use prokinetics for the study duration. * 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
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What it tests

  • Low-dose iron (ferrous sulfate)
  • Yeast-bound iron (ferrous sulfate)
  • High-dose iron (ferrous sulfate)
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Where

1 site
University of Calgary
Calgary, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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