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Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.
The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron dietary supplement on markers of iron status among a sample of premenopausal women that are iron-deficient without anemia. This study will also assess the incidence of mild adverse events (constipation, nausea, etc.) that are relatively common with other over the counter iron dietary supplements and that the investigators hypothesize will be reduced with this lower-dose formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Supplement | Experimental | Participants will consume one tablet of Blood Builder®/Iron Response®, once per day, every day, for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Builder®/Iron Response® | Dietary Supplement | The low-dose iron dietary supplement is a tablet that contains vitamins and minerals selected to help maintain healthy red blood cells and iron levels in the blood. The supplement ingredients aim to generate a supplement by taking a food which contains the naturally occurring, complex matrix of proteins, lipids, carbohydrates and all other elements associated with the vitamin or mineral of interest. These natural food sources are used to generate tablets that maintain the vitamin and mineral potency found in the original food source as well as the associated elements that naturally accompany it. One tablet will be taken once a day offering a total daily serving of:
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hemoglobin (Hgb) Level | Marker of iron status | Baseline and study end (8 weeks from baseline) |
| Changes in Serum Ferritin (SF) Level | Marker of iron status | Baseline and study end (8 weeks from baseline) |
| Changes in Soluble Transferrin Receptor (sTfR) Level | Marker of iron status | Baseline and study end (8 weeks from baseline) |
| Changes in Total Body Iron Stores | Marker of iron status | Baseline and study end (8 weeks from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of self-reported constipation | Study end (8 weeks from baseline) | |
| Frequency and severity of self-reported diarrhea | Study end (8 weeks from baseline) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris D'Adamo, PhD | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Integrative Medicine University of Maryland | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29533710 | Derived | D'Adamo CR, Novick JS, Feinberg TM, Dawson VJ, Miller LE. A Food-Derived Dietary Supplement Containing a Low Dose of Iron Improved Markers of Iron Status Among Nonanemic Iron-Deficient Women. J Am Coll Nutr. 2018 May-Jun;37(4):342-349. doi: 10.1080/07315724.2018.1427158. Epub 2018 Mar 13. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Frequency and severity of self-reported nausea |
| Study end (8 weeks from baseline) |
| Frequency and severity of self-reported vomiting | Study end (8 weeks from baseline) |
| Frequency and severity of self-reported fatigue | Baseline and study end (8 weeks from baseline) |
| Self-reported energy level | Baseline and study end (8 weeks from baseline) |
| Supplement compliance assessed using participant daily diary | Study end (8 weeks from baseline) |
| Adverse events | Study end (8 weeks from baseline) |