Could a Fish-Based pill fix iron deficiency? new study investigates
NCT ID NCT07199244
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well a new iron supplement made from fish (SalmoFer®) is absorbed by the body and whether it causes stomach discomfort. About 61 women aged 21 to 42 with low iron or mild anemia will take the supplement and have their iron levels checked through blood tests. The goal is to see if this marine-based option is a well-tolerated way to improve iron levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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61 people
The number who actually took part.
- Started
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Aug 2024
- Expected to finish
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Oct 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 42 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nutraceuticals Research Institute
Huntsville, Alabama, 35801, United States
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Other studies related to the condition(s) this trial covers.
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