Is NCT07546591 recruiting in Saint Charles, MO?

Yes, NCT07546591 is currently recruiting participants at its Saint Charles, MO location. This iron deficiencies clinical trial is actively enrolling qualified participants.

How do I join the iron deficiencies clinical trial in Saint Charles?

To join this clinical trial in Saint Charles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Saint Charles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Iron Deficiencies Clinical Trial in Saint Charles, MO

About This Iron Deficiencies Study in Saint Charles

This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \<35 µg/L will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily. Primary outcomes include changes in ferritin and hematological parameters. Secondary outcomes include VO₂peak, time to exhaustion, and blood lactate responses during standardized treadmill testing. This study will determine whether lactoferrin enhances iron homeostasis and improves physiological and performance outcomes in exercising women with low iron stores.

Sponsor: Lindenwood University

Who Can Participate

Inclusion Criteria

Women, 18 - 45 years of age

No changes in hormonal contraception use in the past 6 months

Has a regular menstrual cycle defined as five out of the past six months

Engaging in ≥5 hours per week of structured endurance exercise (e.g., running, cycling, swimming, rowing) for the past ≥6 months, with ≥3 sessions per week at moderate-to-vigorous intensity (≥70% HRmax or RPE ≥13).

Training must be consistent, with no interruptions \>2 consecutive weeks in the past 6 months and performed with the purpose of improving performance or preparing for a competition or personal goal.

Exhibit some degree of compromised iron status as depicted by serum ferritin levels below 30 ug/L

Participation in at least one organized endurance event (e.g., races, competitions, or matches) at the recreational, sub-elite, or elite level, or be actively training for a planned competition within the next 6 months.

Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.

No recent or acute infection in the past 30 days and no chronic systemic illness

No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.

If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study

Body mass index (BMI) 18.5 to 32.5 kg/m2 (Inclusive)

Agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to any of the study visits.

Willing and able to maintain consistent diet and physical activity habits

Participants who become pregnant during the course of the study will be removed from participation

Willing and able to provide consent and comply with the protocol

Able to read and understand English at the 6th-grade level and sign the informed consent to participate in the study

Exclusion Criteria

History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery

Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV/AIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)

Acute illness or infection within the past 30 days

History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.

Recently started taking (within the past 90 days or has had their dosage adjusted in the past 90 days) antihypertensives, hypoglycemic medications, GLP1 agonists of any class or type, stimulatory asthma medications, or any other prescription or over-the-counter medication that confound the outcomes measured in this study

Habitual use of anti-inflammatory medications for 30 days prior to providing

Current or past diagnosis of bipolar I/II disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months

Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics

Subject has an allergy to any ingredients in the study product

Subject has a history of drug or alcohol abuse in the past 12 months

Excessive alcohol intake defined as greater than 7 drinks/week or binge episodes

Any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.

Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes

Currently pregnant or lactating

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Saint Charles?

Yes, this clinical trial (NCT07546591) has an active research site in Saint Charles, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Iron Deficiencies Treatment Options in Saint Charles, MO

If you're searching for iron deficiencies treatment options in Saint Charles, MO, this clinical trial (NCT07546591) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Saint Charles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced iron deficiencies specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all iron deficiencies clinical trials near you to find additional studies recruiting in your area.

Iron Deficiencies Clinical Trial in Saint Charles, MO

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