The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females (NCT07199244) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
United States61 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range21 Years – 42 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 …