Status:
ACTIVE_NOT_RECRUITING
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
Lead Sponsor:
Nutraceuticals Research Institute
Conditions:
Anemia
Iron Deficiency (Without Anemia)
Eligibility:
FEMALE
21-42 years
Phase:
NA
Brief Summary
The goal of this study is to identify how well a fish-based iron supplement is absorbed and to learn how many, if any, digestive related side effects are caused by ingesting the supplement.
Detailed Description
This is a single population observational-style trial with a 24-hour pharmacokinetic evaluation. A minimum of 44 healthy adult female consented participants will be screened and classified as low-iron...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
- Lives within 100 miles of a NRI study site
- Biological sex of woman; gender identification of female
- Aged 21 to 42, inclusive
- In luteal phase of menstrual cycle
- Either low levels of iron or mild-moderate iron-deficiency (defined as screening hemoglobin of 12.0-14.0 g/dL or 8.0-11.9 g/dL, respectively)
- Good general health as evidenced by medical history and screening metabolic panel and complete blood count (GMP \& CBC)
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
- Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion
- A positive medical history of heart disease/cardiovascular disease, high blood pressure (140/90 or greater mmHg), kidney disease, hepatic impairment or disease, Type I or Type II diabetes, Irritable bowel disease/Irritable bowel syndrome (IBD/IBS), ulcerative colitis (UC), Crohn's disease or any other medical condition or diagnosis that the PI would deem exclusionary
- A positive surgical medical history for any procedure that may impact iron status (i.e., gastric bypass, gastric pull-up (Roux-en-Y), short bowel syndrome, etc
- A positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within five years before the screening visit.
- A positive medical history of any gastrointestinal disease or illness
- A positive history of any other gastrointestinal surgery that is known to alter or impact the digestion absorption of nutrients and or fluids
- History of hospitalization or in-patient or out-patient treatment for alcohol dependence or drug addiction within the past two years
- History of hospitalization or in-patient treatment for depression or any related condition within the past five years
- Severe iron deficiency (defined as screening hemoglobin \<8.0)
- Pregnancy, trying to conceive, or breastfeeding
- Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year
- Known allergic reactions to any components of the intervention
- Positive COVID-19 test within 30 days of the study period
- Obese, defined as BMI \>35
- Recent dramatic weight changes (10% change in body weight in the last 6 months)
- Existing usage of an iron supplement in any form
- Introducing a new investigational drug or other intervention within 60 days before the start of the study
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT07199244
Start Date
August 1 2024
End Date
October 1 2025
Last Update
September 30 2025
Active Locations (1)
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1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801