The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females

NCT07199244 | Active Not Recruiting

• 1 other identifier: 24-04-2500
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Iron Deficiency (Without Anemia); Iron Absorption

Outcome Measures

Primary Outcomes (5)

• total iron

  total iron measured through blood draws

  baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days

• Ferritin

  total ferritin assessed through blood draws

  baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days

• Transferrin

  transferrin measured through blood draws

  baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days

• hemoglobin

  hemoglogbin

  baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days

• hematocrit

  hematocrit measured through blood draws

  baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days

Secondary Outcomes (1)

• gastrointestinal discomfort

  baseline, 30min, 3 hour, 6 hour, 24 hour, 56 days

Study Arms (1)

Supplement Arm

EXPERIMENTAL

Individuals will consume the supplement for 56 days

Dietary Supplement: marine-based heme iron

Interventions

marine-based heme iron DIETARY_SUPPLEMENT

Participants will consume 9mg of SalmoFer on day 1, followed by 6mg each day for 56 days.

Supplement Arm

Eligibility Criteria

• Age: 21 Years - 42 Years
• Gender Eligibility Details: Biological sex of woman, gender of female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

Location

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to the dose and manufacturer of the supplement.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: August 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: October 1, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)