Iron DeficienciesEFFNCT07546591
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
A study testing Lactoferrin 100 mg, Lactoferrin 300 mg and Iron Supplementation (5 mg) in people with Iron Deficiencies and Low Ferritin, run by Lindenwood University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiencies, Low Ferritin, Iron Deficiency
- What is being tested?
- Lactoferrin 100 mg, Lactoferrin 300 mg and Iron Supplementation (5 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joesi M Morey, MS contact
United States1 site, 1 recruiting
- Recruiting
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
Anthony M Hagele, MS, 6369494785, ahagele@lindenwood.edu
Joesi M Morey, MS, jmorey@lindenwood.edu
About this study
Official title: A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status
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.
Read the detailed description
Iron deficiency is one of the most common micronutrient deficiencies in women, particularly among those who are physically active. Suboptimal iron status can impair oxygen transport, mitochondrial function, and exercise performance. Although oral iron supplementation is commonly used, gastrointestinal side effects may reduce adherence and limit effectiveness. Lactoferrin, an iron-binding glycoprotein, has emerged as a potential adjunct strategy to improve iron regulation and tolerability.
This study will investigate whether supplementation with human recombinant lactoferrin in combination with low-dose iron improves iron status and exercise-related outcomes in exercising women with low ferritin.
Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin <35 µg/L will be recruited. Participants will be stratified by baseline ferritin status (<20 µg/L or 20-35 µg/L) and randomized in a double-blind, parallel-group design to receive one of the following for 8 weeks:
100 mg lactoferrin + 5 mg iron 300 mg lactoferrin + 5 mg iron Placebo + 5 mg iron Participants will complete six study visits including screening, baseline, and follow-up assessments at weeks 2, 4, 6, and 8. Assessments will include venous blood sampling for iron-related biomarkers and hematological parameters, as well as inflammatory and metabolic markers. Aerobic performance will be evaluated using VO₂peak testing and time-to-exhaustion treadmill protocols with serial blood lactate measurements.
Additional measures include gastrointestinal symptoms, menstrual symptoms, quality of life, and perceived recovery. Daily supplementation compliance and adverse events will be monitored throughout the intervention.
This trial will provide insight into the role of lactoferrin as an adjunct to iron supplementation for improving iron homeostasis and performance outcomes in active women.
- Being tested
- Lactoferrin 100 mg, Lactoferrin 300 mg, Iron Supplementation (5 mg)
- Keywords
- lactoferrin, effera, iron supplementation, iron metabolism, ferritin, aerobic performance, vo2peak, endurance exercise, time to exhaustion, lactate metabolism, female athletes, exercising females, menstruating women, iron bioavailability, nutritional supplementation
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin 100 mgDietary supplement
Human recombinant lactoferrin administered at a dose of 100 mg daily for 8 weeks.
Lactoferrin 300 mgDietary supplement
Human recombinant lactoferrin administered at a dose of 300 mg daily for 8 weeks.
Iron Supplementation (5 mg)Dietary supplement
Oral iron supplementation provided at a dose of 5 mg daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Lactoferrin + Iron | Experimental | Participants will consume 100 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks. Receives: Dietary Supplement: Lactoferrin 100 mg; Dietary Supplement: Iron Supplementation (5 mg) |
| High-Dose Lactoferrin + Iron | Experimental | Participants will consume 300 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks. Receives: Dietary Supplement: Lactoferrin 300 mg; Dietary Supplement: Iron Supplementation (5 mg) |
| Placebo + Iron | Placebo comparator | Participants will consume a placebo combined with 5 mg iron daily for 8 weeks. Receives: Dietary Supplement: Iron Supplementation (5 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Ferritin Concentration
Serum ferritin concentration will be assessed via venous blood samples to evaluate changes in iron storage over the intervention period.
Measured: Baseline, Weeks 2, 4, 6, and 8
Secondary outcomes (15)
Change in Hemoglobin
Hemoglobin concentration measured from venous blood samples. Higher values indicate improved oxygen-carrying capacity.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Hematocrit
Percentage of red blood cells in blood volume. Higher values indicate increased red cell mass.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Red Blood Cell Count
Total number of red blood cells per unit volume of blood. Higher values indicate increased erythropoiesis.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Serum Iron
Serum iron concentration measured from venous blood samples.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Total Iron Binding Capacity
Measure of blood's capacity to bind iron with transferrin.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Transferrin Saturation
Percentage of transferrin bound to iron. Higher values indicate improved iron availability.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in Hepcidin Concentration
Circulating hepcidin levels reflecting iron regulatory activity. Lower levels generally indicate increased iron availability.
Measured: Baseline, Weeks 2, 4, 6, and 8
Change in VO₂Peak
VO₂Peak will be assessed using a graded treadmill test with indirect calorimetry to evaluate maximal aerobic capacity. Higher values indicate improved aerobic performance.
Measured: Baseline, Week 4, and Week 8
Change in Time to Exhaustion During Treadmill Testing
Time to exhaustion will be measured during a standardized treadmill protocol. Longer time to exhaustion indicates improved endurance performance.
Measured: Baseline, Week 4, and Week 8
Change in Ventilatory Threshold (%VO₂Peak)
Ventilatory threshold will be expressed as a percentage of VO₂Peak during graded exercise testing. Higher values indicate improved submaximal aerobic efficiency.
Measured: Baseline, Week 4, and Week 8
Change in Blood Lactate Concentrations During Exercise
Capillary blood lactate will be measured at rest and during standardized treadmill stages (70%, 80%, 85%, and 90% VO₂Peak). Lower lactate at a given workload indicates improved metabolic efficiency.
Measured: Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptoms Rating Scale (GSRS) Score
The GSRS is a 15-item questionnaire assessing gastrointestinal symptoms, scored on a 7-point Likert scale (1 = no discomfort, 7 = very severe discomfort). Lower scores indicate fewer symptoms.
Measured: Baseline, Week 4, and Week 8
Change in Menstrual Symptoms Questionnaire Score
The MSQ-24 assesses severity and frequency of menstrual-related symptoms. Higher scores indicate greater symptom burden.
Measured: Baseline, Week 4, and Week 8
Change in Health-Related Quality of Life (SF-36) Score
The SF-36 evaluates multiple domains of health-related quality of life. Higher scores indicate better perceived health status.
Measured: Baseline, Week 4, and Week 8
Change in Perceived Recovery Scale Score
Perceived recovery will be assessed using a 0-10 scale, where 0 indicates very poorly recovered and 10 indicates fully recovered. Higher scores indicate better recovery status.
Measured: Baseline, Weeks 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified by baseline ferritin status (\<20 µg/L or 20-35 µg/L) and randomized in a parallel-group design to receive one of three interventions for 8 weeks: (1) 100 mg human lactoferrin + 5 mg iron, (2) 300 mg human lactoferrin + 5 mg iron, or (3) placebo + 5 mg iron. All groups will consume their assigned supplement daily throughout the intervention period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546591
- Sponsor's protocol ID
- IRB-26-88
- Acronym
- EFF
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. Study results will be reported in aggregate form, and no identifiable data will be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status
- ClinicalTrials.gov ID
- NCT07546591
- Acronym / sponsor ID
- EFF / IRB-26-88
- Keywords
- lactoferrin, effera, iron supplementation, iron metabolism, ferritin, aerobic performance, vo2peak, endurance exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Iron deficiency is one of the most common micronutrient deficiencies in women, particularly among those who are physically active. Suboptimal iron status can impair oxygen transport, mitochondrial function, and exercise performance. Although oral iron supplementation is commonly used, gastrointestinal side effects may reduce adherence and limit effectiveness. Lactoferrin, an iron-binding glycoprotein, has emerged as a potential adjunct strategy to improve iron regulation and tolerability.
This study will investigate whether supplementation with human recombinant lactoferrin in combination with low-dose iron improves iron status and exercise-related outcomes in exercising women with low ferritin.
Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin <35 µg/L will be recruited. Participants will be stratified by baseline ferritin status (<20 µg/L or 20-35 µg/L) and randomized in a double-blind, parallel-group design to receive one of the following for 8 weeks:
100 mg lactoferrin + 5 mg iron 300 mg lactoferrin + 5 mg iron Placebo + 5 mg iron Participants will complete six study visits including screening, baseline, and follow-up assessments at weeks 2, 4, 6, and 8. Assessments will include venous blood sampling for iron-related biomarkers and hematological parameters, as well as inflammatory and metabolic markers. Aerobic performance will be evaluated using VO₂peak testing and time-to-exhaustion treadmill protocols with serial blood lactate measurements.
Additional measures include gastrointestinal symptoms, menstrual symptoms, quality of life, and perceived recovery. Daily supplementation compliance and adverse events will be monitored throughout the intervention.
This trial will provide insight into the role of lactoferrin as an adjunct to iron supplementation for improving iron homeostasis and performance outcomes in active women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be stratified by baseline ferritin status (<20 µg/L or 20-35 µg/L) and randomized in a parallel-group design to receive one of three interventions for 8 weeks: (1) 100 mg human lactoferrin + 5 mg iron, (2) 300 mg human lactoferrin + 5 mg iron, or (3) placebo + 5 mg iron. All groups will consume their assigned supplement daily throughout the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Lactoferrin + Iron | Experimental | Dietary Supplement: Lactoferrin 100 mg, Dietary Supplement: Iron Supplementation (5 mg)Participants will consume 100 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks. |
| High-Dose Lactoferrin + Iron | Experimental | Dietary Supplement: Lactoferrin 300 mg, Dietary Supplement: Iron Supplementation (5 mg)Participants will consume 300 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks. |
| Placebo + Iron | Placebo comparator | Dietary Supplement: Iron Supplementation (5 mg)Participants will consume a placebo combined with 5 mg iron daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin 100 mgHuman recombinant lactoferrin administered at a dose of 100 mg daily for 8 weeks. | Dietary supplement | Low-Dose Lactoferrin + Iron |
| Lactoferrin 300 mgHuman recombinant lactoferrin administered at a dose of 300 mg daily for 8 weeks. | Dietary supplement | High-Dose Lactoferrin + Iron |
| Iron Supplementation (5 mg)Oral iron supplementation provided at a dose of 5 mg daily for 8 weeks. | Dietary supplement | High-Dose Lactoferrin + Iron, Low-Dose Lactoferrin + Iron, Placebo + Iron |
Primary outcome
Change in Serum Ferritin Concentration
Time frame: Baseline, Weeks 2, 4, 6, and 8
Serum ferritin concentration will be assessed via venous blood samples to evaluate changes in iron storage over the intervention period.
15 secondary outcomes
Change in Hemoglobin
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Hematocrit
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Red Blood Cell Count
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Serum Iron
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Total Iron Binding Capacity
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Transferrin Saturation
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in Hepcidin Concentration
Time frame: Baseline, Weeks 2, 4, 6, and 8
Change in VO₂Peak
Time frame: Baseline, Week 4, and Week 8
Change in Time to Exhaustion During Treadmill Testing
Time frame: Baseline, Week 4, and Week 8
Change in Ventilatory Threshold (%VO₂Peak)
Time frame: Baseline, Week 4, and Week 8
Change in Blood Lactate Concentrations During Exercise
Time frame: Baseline, Week 4, and Week 8
Change in Gastrointestinal Symptoms Rating Scale (GSRS) Score
Time frame: Baseline, Week 4, and Week 8
Change in Menstrual Symptoms Questionnaire Score
Time frame: Baseline, Week 4, and Week 8
Change in Health-Related Quality of Life (SF-36) Score
Time frame: Baseline, Week 4, and Week 8
Change in Perceived Recovery Scale Score
Time frame: Baseline, Weeks 2, 4, 6, and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. Study results will be reported in aggregate form, and no identifiable data will be disclosed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joesi M Morey, MS contact
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin 100 mg, Lactoferrin 300 mg and Iron Supplementation (5 mg) in people with Iron Deficiencies and Low Ferritin, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony M Hagele, MS (6369494785, ahagele@lindenwood.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Ferritin Concentration (time frame: Baseline, Weeks 2, 4, 6, and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.