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New treatment option for Iron Deficiencies
Official title A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
ClinicalTrials.gov ID: NCT07546591
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Training must be consistent, with no interruptions \>2 consecutive weeks in the past 6 months and performed with the purpose of improving performance...
You likely can't join if
- History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel...
- Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90...
- 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...
- Habitual use of anti-inflammatory medications for 30 days prior to providing
See the full eligibility criteria
Who can join
- 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)
- Non-smoker
- 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
What rules you out
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Saint Charles, Missouri, United States
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, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Charles, Missouri, United States. 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.