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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
61
Participants will consume 9mg of SalmoFer on day 1, followed by 6mg each day for 56 days.
Nutraceuticals Research Institute
Huntsville, Alabama, United States
total iron
total iron measured through blood draws
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
Ferritin
total ferritin assessed through blood draws
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
Transferrin
transferrin measured through blood draws
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
hemoglobin
hemoglogbin
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
hematocrit
hematocrit measured through blood draws
Time frame: baseline, 30min, 60 min, 3 hour, 6 hour, 12 hour, 24 hour, 56 days
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
Time frame: baseline, 30min, 3 hour, 6 hour, 24 hour, 56 days
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