AnemiaNCT07199244
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
A study testing marine-based heme iron in people with Anemia and Iron Deficiency (Without Anemia), run by Nutraceuticals Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency (Without Anemia), Iron Absorption
- What is being tested?
- marine-based heme iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Oct 2025
- 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 21 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutraceuticals Research Institute
Huntsville, Alabama, 35801
About this study
Official title: The Immediate and Long-term Effects of Oral Administration of SalmoFer®, a Novel Marine-based Heme Iron Supplement, in Adult Females
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.
Read the 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 levels or anemic. Both classifications receive active iron supplements as a single group. Participants will provide data on the outcome measures of safety, vital signs, iron levels from whole blood collection, and subjective experience. Blood collection will take place at baseline, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after ingestion. All data will be taken at baseline and again at day 56, after daily intake of the supplement.
- Conditions
- Anemia, Iron Deficiency (Without Anemia), Iron Absorption
- Being tested
- marine-based heme iron
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marine-based heme ironDietary supplement
Participants will consume 9mg of SalmoFer on day 1, followed by 6mg each day for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Supplement Arm | Experimental | Individuals will consume the supplement for 56 days Receives: Dietary Supplement: marine-based heme iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
total iron
total iron measured through blood draws
Measured: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
Ferritin
total ferritin assessed through blood draws
Measured: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
Transferrin
transferrin measured through blood draws
Measured: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
hemoglobin
hemoglogbin
Measured: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
hematocrit
hematocrit measured through blood draws
Measured: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
Secondary outcomes (1)
gastrointestinal discomfort
GI Discomfort is measured through a self-report scale which produces scores ranging from 1-5, with higher scores indicating higher levels of discomfort
Measured: baseline, 30min, 3 hour, 6 hour, 24 hour, 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Aug 2024
- Primary completion31 May 2025
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Hawkins, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199244
- Sponsor's protocol ID
- 24-04-2500
- Status last verified
- Jan 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may not be shared without a valid IRB authorization and consent of all study participants.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate and Long-term Effects of Oral Administration of SalmoFer®, a Novel Marine-based Heme Iron Supplement, in Adult Females
- ClinicalTrials.gov ID
- NCT07199244
- Acronym / sponsor ID
- 24-04-2500
- Conditions
- Anemia, Iron Deficiency (Without Anemia), Iron Absorption
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 Sep 2025 (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.
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 levels or anemic. Both classifications receive active iron supplements as a single group. Participants will provide data on the outcome measures of safety, vital signs, iron levels from whole blood collection, and subjective experience. Blood collection will take place at baseline, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after ingestion. All data will be taken at baseline and again at day 56, after daily intake of the supplement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplement Arm | Experimental | Dietary Supplement: marine-based heme ironIndividuals will consume the supplement for 56 days |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| marine-based heme ironParticipants will consume 9mg of SalmoFer on day 1, followed by 6mg each day for 56 days. | Dietary supplement | Supplement Arm |
Primary outcome
total iron
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
total iron measured through blood draws
Ferritin
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
total ferritin assessed through blood draws
Transferrin
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
transferrin measured through blood draws
hemoglobin
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
hemoglogbin
hematocrit
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
hematocrit measured through blood draws
1 secondary outcome
gastrointestinal discomfort
Time frame: baseline, 30min, 3 hour, 6 hour, 24 hour, 56 days
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 30 Sep 2025.
- Individual participant dataSharing planned: No. IPD may not be shared without a valid IRB authorization and consent of all study participants.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing marine-based heme iron in people with Anemia and Iron Deficiency (Without Anemia), run by Nutraceuticals Research Institute 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 10 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total iron (time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days). The study lists 5 primary outcomes in all. 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 30 Sep 2025.