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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement Arm | Experimental | Individuals will consume the supplement for 56 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| marine-based heme iron | Dietary Supplement | Participants will consume 9mg of SalmoFer on day 1, followed by 6mg each day for 56 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 30min, 3 hour, 6 hour, 24 hour, 56 days |
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Inclusion Criteria:
Exclusion Criteria:
Biological sex of woman, gender of female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutraceuticals Research Institute | Huntsville | Alabama | 35801 | United States |
IPD may not be shared without a valid IRB authorization and consent of all study participants.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Participants are blinded to the dose and manufacturer of the supplement.
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| D009750 | Nutritional and Metabolic Diseases |