NCT07199244

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

The Immediate and Long-term Effects of Oral Administration of SalmoFer®, a Novel Marine-based Heme Iron Supplement, in Adult Females

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Nutraceuticals Research Institute · Academic / Other
• Sex: Female
• Age: 21 Years – 42 Years
• Healthy volunteers: Accepted

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 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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	marine-based heme iron	Participants will consume 9mg of SalmoFer on day 1, followed by 6mg each day for 56 days.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-05-31
• Completion: 2025-10-01
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States