Status:
COMPLETED
Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels
Lead Sponsor:
Applied Science & Performance Institute
Conditions:
Iron Deficiency (Without Anemia)
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal...
Detailed Description
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal...
Eligibility Criteria
Inclusion
- Healthy female subjects \> 18 years old
- Premenopausal (experiencing regular menstrual cycles)
- Hemoglobin \> 11g/dL
- Serum ferritin \< 70 ng/mL
- hs-CRP \< 3 mg/L
- BMI 18 - 29.9 kg/m2
- No intake of dietary supplements containing iron 30 days prior to enrollment
- Willing and able to give written informed consent
- Able to read, understand, sign and date the informed consent document (English only)
- Able and willing to comply with the schedule visit(s) and study requirements.
Exclusion
- Currently taking (within the past 14 days) dietary supplements including, vitamins (any), minerals, protein shakes, vitamin water, other supplements
- History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Prior health issues showing high CRP or other inflammatory markers
- Pregnancy or has breast fed within 3 months prior to enrollment
- BMI \<18 or \>25 kg/m2
- Diagnosis of a terminal illness
- Use of prescription medications that impact digestion (i.e., proton pump inhibitor medications, other)
- History of alcohol abuse
- History or current drug abuse
- History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
- Insulin-dependent diabetes and/or metformin use
- Chronic kidney or liver disease
- Anemia
- Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
- The investigator feels that for any reason the subject is not eligible to participate in the study
- Use within 24 hours preceding enrollment of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia)
- History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- History, or current bleeding disorders (i.e., hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
- A family member of the investigator or an employee of the investigator
- Participation in any other investigational study within 30 days prior to consent
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05257343
Start Date
February 7 2022
End Date
December 9 2022
Last Update
May 30 2023
Active Locations (1)
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1
The Applied Science and Performance Institute
Tampa, Florida, United States, 33607