Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 55
Updated:9/29/2017
Start Date:February 2016
End Date:May 2017

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Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women

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.

Inclusion Criteria:

1. Pre-menopausal

2. Iron deficient without anemia (serum ferritin concentration < 20 ug/L and a hemoglobin
concentration > 120 g/L)

3. Agree to continue with current diet and any dietary supplements

4. Able to understand and write English

5. Voluntarily consent to the study and understand its nature and purpose including
potential risks and side effects

Exclusion Criteria:

1. Daily supplementation of another iron supplement (other than multivitamin) currently
or within past 2 weeks

2. Pregnant or breastfeeding females

3. History of alcohol, drug, or medication abuse

4. Known allergies to any substance in the study product

5. Donated blood in the past month or plan to do so at any time during the 8-week trial

6. Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis)

7. Taking medication that my interfere with the absorption of iron

8. Current tobacco smoker
We found this trial at
1
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Baltimore, Maryland 21201
Phone: 410-440-2620
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Baltimore, MD
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